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Transcript
Nationwide Children’s Hospital
Extra-Corporeal Life Support Services (ECLS)
Guideline and Training Manual
2011
Approval by:
Date: mm/dd/yyyy
Onsy Ayad MD _____________________________
___/___/_____
Louis Chicoine MD __________________________
___/___/_____
Alistair Phillips MD __________________________
___/___/_____
Steven Teich MD ___________________________
___/___/_____
Daniel Gomez CCP __________________________
___/___/_____
Vincent F. Olshove CCP ______________________
___/___/_____
Thomas J. Preston CCP ______________________
___/___/_____
1
INTRODUCTION ..................................................................................................................... 5
MISSION STATEMENT ............................................................................................................ 6
ECMO INITIATION – ROLES AND RESPONSIBILITIES ................................................................ 6
ECMO SET-UP, PRIME & MANAGEMENT ...............................................................................11
Fully Assembled Circuit Diagram................................................................................................................... 11
Circuit Assembly .......................................................................................................................................... 12
Priming Matrix ............................................................................................................................................. 17
Circuit Crystalloid Prime ............................................................................................................................... 18
Circuit Blood Prime ...................................................................................................................................... 23
EMERGENCY Prime for Rapid Deployment .................................................................................................... 28
Initiation of ECMO Flow ............................................................................................................................... 33
Bridge Opening & Maintenance ............................................................................................................................................................................................................ 34
Removal From & Return to ECMO Support ................................................................................................... 37
Weaning ...................................................................................................................................................... 38
Trial off ........................................................................................................................................................ 40
Flushing Bridge with Crystalloid ............................................................................................................................................................................................................ 41
Cannulae Stenting Procedure ....................................................................................................................... 42
Removal from ECMO support ....................................................................................................................... 43
Terumo CDI 500™ in-line blood gas monitor setup & management ................................................................ 44
Blood Gas Management for the ECMO Patient .............................................................................................. 46
“Sighing” the Oxygenator ............................................................................................................................. 48
Oxygenator Failure Diagnosis ....................................................................................................................... 49
Drawing a Blood Sample .............................................................................................................................. 50
Venous Blood Sampling ......................................................................................................................................................................................................................... 50
Bridge closed ......................................................................................................................................................................................................................................... 50
Bridge Open .......................................................................................................................................................................................................................................... 51
COMPONENT CHANGEOUT ...................................................................................................52
ECMO Circuit Changeout .............................................................................................................................. 52
Quadrox D/ iD membrane oxygenator set up, prime and changeout ............................................................. 60
2
Better Bladder™ changeout .......................................................................................................................... 64
Raceway prime and changeout ..................................................................................................................... 66
Heater Changeout ........................................................................................................................................ 67
Roller Pump Changeout................................................................................................................................ 68
Jostra RotaFlow™ Centrifugal Pump Changeout ............................................................................................ 70
Stopcock Changeout .................................................................................................................................... 71
Pigtail Changeout ......................................................................................................................................... 72
ZEROING PRESSURE TRANSDUCERS ..........................................................................................73
HAND-CRANKING THE JOSTRA® ROLLER PUMP ....................................................................74
HAND-CRANKING THE JOSTRA® ROTAFLOW CENTRIFUGAL PUMP .......................................76
OCCLUSION- SETTING THE OCCLUSION ON THE ROLLER PUMP .............................................78
RACEWAY WALKING .............................................................................................................80
AIR-FREE CONNECTION OR FLUID FILLED CONNECTION ........................................................81
AIR REMOVAL .......................................................................................................................82
FLUID INFUSION ...................................................................................................................84
TRANSPORT OF PATIENT ON ECMO ......................................................................................86
ULTRAFILTRATION- TERUMO HC05S™ SETUP AND MANAGEMENT ..............................................87
HEMORRHAGE PROTOCOL....................................................................................................89
NICU/PICU Hemorrhage Protocol ................................................................................................................. 89
Cardiac Bleeding Protocol (>10mL/Kg) .......................................................................................................... 92
BLOOD PRODUCTS – TRANSFUSION SERVICES ......................................................................95
Blood Product Administration – Packed Red Blood Cells (PRBC) .................................................................... 95
Blood Product Administration – Fresh Frozen Plasma (FFP, Plasma) .............................................................. 99
3
Blood Product Administration – Platelets ................................................................................................... 100
Blood Product Administration – Cryoprecipitate (Cryo) ............................................................................... 102
MEDICATIONS .................................................................................................................... 103
Heparin Infusion, Xa - Administration & Management ................................................................................ 103
Medication Administration – Epsilon-Aminocaproic Acid (Amicar) .............................................................. 106
Medication Administration – Antithrombin (ATIII) ...................................................................................... 107
Medication Administration – rFVIIa (NovoSeven, Factor VII) ....................................................................... 108
Medication Administration – Argatroban.................................................................................................... 109
MEDICATION RECOMMENDATIONS FOR THE ECMO PATIENT ...................................................................... 112
MEDICATIONS NOT APPROVED FOR ECMO ADMINISTRATION ..................................................................... 113
LABORATORY ..................................................................................................................... 114
Performing Activated Clotting Time Test (ACT)............................................................................................ 114
Laboratory Tests, Tube Colors and Volumes ................................................................................................ 116
Drawing Blood Cultures.............................................................................................................................. 119
CANNULAE ......................................................................................................................... 120
Biomedicus Arterial Cannulae .................................................................................................................... 120
Biomedicus Venous Cannulae ..................................................................................................................... 123
VA Cannulae Flow Charts ........................................................................................................................... 126
VV Cannulae .............................................................................................................................................. 127
Avalon VV cannulae ................................................................................................................................... 135
PRODUCT SPECIFICATIONS ................................................................................................. 142
Hemochron™ Response.............................................................................................................................. 142
Circulatory Technology Inc. - Better Bladder™ and Bigger Better Bladder™ .................................................. 143
Terumo CDI 500™ in-line blood gas monitor ............................................................................................... 145
Heater- Cincinnati Sub Zero ........................................................................................................................ 146
Maquet Quadrox iD & D® oxygenator.......................................................................................................... 150
4
Thromboelastography (TEG®) ..................................................................................................................... 151
Transonic™ Flowmeter ............................................................................................................................... 154
Tubing ........................................................................................................................................................ 155
Ultrafiltration- Terumo HC05S™ ................................................................................................................. 157
APPENDIX ........................................................................................................................... 158
Cardiac ECMO Activation Sequence ............................................................................................................ 158
ECMO Specialist Shift Report Form ............................................................................................................. 159
ELSO CENTER GUIDELINES................................................................................................... 160
ELSO GUIDELINES FOR TRAINING ........................................................................................ 163
ELSO GUIDELINES FOR NEONATAL ECMO CENTERS (VIA ELSO WEBSITE) ............................. 167
NCH CENTER GUIDELINES ................................................................................................... 173
ROUTINE CARE ................................................................................................................... 177
JOB DESCRIPTIONS ............................................................................................................. 180
Coordinator ............................................................................................................................................... 180
ECMO Primer ............................................................................................................................................. 182
ECMO Bedside Specialist ............................................................................................................................ 184
NCH GUIDELINES FOR TRAINING ......................................................................................... 185
NCH GUIDELINES FOR NEONATAL ECMO FOLLOWUP .......................................................... 186
Neonatal Follow-up Parent letter ............................................................................................................... 189
Introduction
The ECMO guidelines contained within this publication have been developed, reviewed and approved by the ECMO
medical directors, manager and coordinators. It is therefore intended that this guideline will serve as the basis for the
5
initiation, progression and termination of ECMO at Nationwide Children’s hospital and to improve the continuity of care
we provide to the ECMO patient. It is not the intent of this manual to determine appropriate care for all ECMO patients.
The complex care ECMO patients require dictates that guidelines, common sense, experience and continuous
communication between the physicians and the specialists be present at all times.
Whenever there is a departure from these guidelines, it is imperative that the ECMO primer, specialist or perfusionist
and the attending physician have open meaningful discussion regarding the actions about to be undertaken.
Mission Statement
As an ECMO team, it is our mission to provide the best evidence-based care possible to all patients that require ECMO
support until such a time that the physician, family or the patient determines further support will/would be of no further
benefit.
ECMO Initiation – Roles and Responsibilities
Personnel: ECMO Specialist, ECMO Primer or Perfusionist, Bedside RN, ECMO Physician, Surgeon
Equipment:
ECMO Pump
ACT Machine
ACT Tubes
X-ray plate
ECMO bed (adjustable height bed, sport bed/infant warmer)
Medication per NCH ECMO prime matrix
Blood products per NCH ECMO prime matrix
ECMO heparin bag D5 (concentration 100 units Heparin/ml)
Pre ECMO:
o Laboratory samples
o Neonate –
 Head ultrasound
 ECHO
o Neurological evaluation
Outcome:
Fully prepared ECMO circuit, patient and room for ECMO cannulation.
ECMO Physician/Resident/Fellow/Advance Practice Nurse/Charge Nurse/Unit Clerk:
NICU:
1. NICU attending physician:
Obtains guardian consent for ECMO
Call pediatric general surgeon
Instruct Charge Nurse to contact the hospital operator.
6
2. Charge Nurse:
Call Hospital Operator (0):
Give the hospital operator the following information; unit, bed space, diagnosis and weight. The
hospital operator will then activate the ECMO team.
3. Resident/Fellow or Advance Practice Nurse:
Activate Neonatal ECMO pre-ECMO lab order set
CBC w/diff, PT, aPTT, Fibrinogen, D-dimer, AST, ALT, BUN, Creatinine, Electrolytes,
Glucose, Lactate, Plasma Free Hgb, Total Protein, Albumin, Alk Phosphate, iCa++,
Bilirubin, PKU, Cultures- Blood-Bone Marrow and Isolator, Neonatal workup for
patients < 4 months, > 4 months type and screen.
Order cardiac ECHO.
Order head ultrasound (HUS).
Activate Neonatal ECMO cannulation order set.
Order: 2 units PRBC, 1 unit FFP and 120mL Platelets
PICU:
1. PICU attending physician:
Obtains guardian/patient consent for ECMO
Call pediatric general surgeon
Instruct Charge Nurse to contact the hospital operator.
2. Charge Nurse:
Call Hospital Operator (0):
Give the hospital operator the following information; unit, bed space, diagnosis and weight. The
hospital operator will then activate the ECMO team.
3. Resident/Fellow or Advance Practice Nurse:
Activate Pediatric ECMO pre-ECMO lab order set :
1. CBC w/diff, PT, aPTT, Fibrinogen, AST, ALT, LDH, BUN, Creatinine, Electrolytes, Glucose,
Lactate, Plasma Free Hgb, Total Protein, Albumin, Alk Phosphate, iCa++, PKU, D-Dimer, Total
bilirubin, GGTP, Uric Acid, Cultures- Blood-Bone Marrow and Isolator, Sputum- Bacterial,
fungal and anaerobic, Neonatal workup for patients < 4 months, > 4 months type and
screen.
Consider cardiac ECHO.
Activate Pediatric ECMO cannulation order set
Order:
Pt’s < 10Kg : 2 unit PRBC’s and 1 unit FFP and 120mL platelets
7
Pt’s 10 – 30Kg : 2 units PRBC’s and 2 units FFP
Pt’s > 30Kg : 3 units PRBC’s and 2 units FFP
CICU:
1. CICU attending physician contacts the CV surgeon on call.
If decision is made to place patient on ECMO, proceed with below steps
2. CICU attending physician:
Obtains guardian/patient consent.
Instruct Charge Nurse to contact the Operating Room front desk (24100) and the hospital
operator.
3. Charge Nurse:
Call the OR front desk (24100):
Inform them that the patient in bed space __ is going to be placed on cardiac ECMO, the
patient’s weight is__.
Ask OR to call perfusionist AND cardiac nurses on call.
Ask OR nurse to bring cardiac ECMO cart, headlight, room 1 bovie, surgeon loupes and CV travel
box to CICU bed space __.
Call Hospital Operator (0):
Give the hospital operator the following information; unit, bed space, cardiac ECMO and weight.
The hospital operator will then activate the ECMO team pagers.
4. Resident/Fellow or Advance Practice Nurse:
Activate Cardiac ECMO pre-ECMO lab order set:
CBC w/diff, PT, aPTT, Fibrinogen, AST, ALT, LDH, BUN, Creatinine, Electrolytes, Glucose,
Lactate, Plasma Free Hgb, Total Protein, Albumin, Alk Phosphate, iCa++, PKU, D-Dimer, Total
bilirubin, GGTP, Uric Acid, Neonatal workup for patients < 4 months, > 4 months type and
screen.
Consider cardiac ECHO.
Consider head ultrasound (HUS).
Activate Cardiac ECMO cannulation order set.
Order:
Pt’s < 10Kg : 2 unit PRBC’s and 1 unit FFP and 120mL platelets
Pt’s 10 – 30Kg : 2 units PRBC’s and 2 units FFP
Pt’s > 30Kg : 3 units PRBC’s and 2 units FFP
ECMO Primer or Perfusionist:
8
If already in-house; report to ECMO bedside and discuss situation with ECMO physician. If responding from home,
immediately call in to patient bedside and talk to the ECMO physician. The ECMO physician will describe the current
situation and make the decision for either a blood or crystalloid initiation. This call also serves to inform others that
you are in route to the hospital.
Specific responsibilities:
1. Confirm with ECMO specialist that blood bank is preparing blood products.
2. Confirm x-ray placed under patient or in X-ray drawer.
3. Follow NCH ECMO Circuit Crystalloid/Blood Prime procedure in selecting and preparing ECMO circuit or
physician orders.
4. Calculate full flow and choose appropriate cannulae.
5. Complete crystalloid/blood prime and prepare to hand off the arterial and venous lines.
ECMO Specialist:
The ECMO specialist must be available once the decision to cannulate has been made by the ECMO physician. A
primary responsibility of the specialist will be to assist the ECMO Primer/perfusionist with the preparation of the
ECMO circuit. The specialist will function under the direction of the ECMO primer/perfusionist during cannulation
and the initiation of ECMO. Following initiation, the ECMO specialist will continue to serve as the ECMO bedside
specialist.
Specific responsibilities:
1. Call the blood bank (25391) and provide them with your name and title, and the patients name and MRN
confirm that the blood and FFP are being prepared.
2. If an appropriately sized crystalloid primed circuit is available, move it into hallway outside of ECMO room. Make
sure that the circuit is plugged in. Turn pump on and begin recirculating at 500mL/min.
3. Obtain 3 bottles (1L ea.) of sterile water to fill heater reservoir (if not previously done). Attach heater hoses to
oxygenator, turn heater on, set temperature to 38 degrees.
4. Verify that ECMO orders were entered.
5. Obtain Hemochron Resonse. ACT machine (with ACT Tubes). Perform ESV procedure.
6. Prepare the following additives for circuit priming:
2- Albumin 25%
5- Heparin (prime blood products)
1- Heparin (pt. loading dose)
1- THAM
1- NaHCO3 (1mEq/ml)
1- Calcium Chloride
50 ml/syringe
200 units/syringe
200 units/kg
30 ml
50 ml
2000 mg (100 mg/ml)
7. Obtain X-ray plate and place under patient or in X-ray drawer.
9
8. Assist bedside nurse with removal of furniture or equipment not needed for cannulation.
9. Prime IV tubing with heparin drip (100units/ml in D5W) once available from pharmacy.
10. Obtain ECMO flush (1unit heparin/mL) syringes from pyxis.
11. From the ECMO carts prepare the following items:
ECMO Flowsheets
Alcohol wipes
Gloves
Chux pads
Syringes (60ml, 3ml, 1ml)
Bedside RN:
1. Ensure patient is on an ECMO bed.
2. Ensure patient is in the proper orientation for ECMO within the ECMO bed.
3. Draw and send pre-ECMO laboratory samples.
4. Facilitate head ultrasound and cardiac ECHO as needed.
5. Remove all unnecessary furniture from the patient room.
6. Activate three whole blood batteries, print and have available at patient bedside.
7. Move all IV pumps out of the surgeons, 1st assistants and ECMO pump area.
8. Assist surgical team with placement of Bovie grounding pad.
9. Position IV/arterial access ports out of sterile field with extension line if needed.
10. Draw up blood products/volume expanders as requested by the ECMO physician.
11. Maintain at least one port outside of the sterile field to administer the heparin bolus according to
physician/surgeon’s instructions.
12. Document vital signs during cannulation procedure Q5 minutes.
10
ECMO Set-up, prime & management
Fully Assembled Circuit Diagram
11
Circuit Assembly
Personnel:
ECMO Primer
Perfusionist
Equipment:
Select appropriate tubing pack:
o 2-10Kg (1/4 x 1/4), >10-20Kg (1/4 x 3/8), 21-30Kg (1/4 x 3/8 Centrifugal), >30Kg (3/8 x 3/8 Centrifugal)
Quadrox D® oxygenator / Quadrox iD® for patients 2-10Kg
Disposable centrifugal pump (1/4 x 3/8 and 3/8 x 3/8 circuit)
3- Pressure transducers
Appropriate size Better BladderTM
o BB14 (1/4” better bladder)
o BBB38 (3/8” bigger better bladder)
1 or 2- 1000mL suction canisters
1- Suction tubing
Personnel protective equipment
o Hat
o Mask
o Sterile gloves (if gross circuit manipulation is required)
Scalpel blade
3- liters sterile H2O (CSZ heater)
10mL syringe
6- 2-way stopcocks
1- 3-way stopcock
1- 6” pigtail
1- 2’ pressure line
3- Parallel “Y’s”
3- 2 inch hemofilter stubs
Hemofilter
CDI tubing pack
*** SEE ROLLER PUMP CIRCUIT DIAGRAM BELOW ***
or
*SEE CENTRIFUGAL PUMP DIAGRAM BELOW*
Outcome:
Fully assembled sterile ECMO circuit. This assembled circuit and corresponding pump will be easily wet
primed for rapid use.
Goal: Once setup, the dry ECMO circuit may be utilized for up to one year. It is therefore important to check all
expiration dates when assembling the circuit, as all expiration dates must be greater than one year from the date
of assembly.
12
Steps:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
Verify expiration dates on all supplies.
Check all packages for: tears, holes, water marks, sterilization confirmation.
Write all Lot #’s on the NCH Jostra Prime Checklist.
Put on hat and mask.
Place one or both suction canisters in holder.
Open all transducers, make connection to transducer cable, and place in holder in the corresponding position (PreOx = Left, Post-Ox = Center, Bladder = Right).
Open Quadrox D® or Quadrox iD® oxygenator and place in holder (Venous (blue) cap toward you). Place 1/4” stub on
the 1/4” post oxygenator port if present, attach 2-way stopcock and close. Place dead-ender cap on open end of
stopcock.
Open Bladder (BB14 or BBB38) and place in holder with pressure transducer port at top. Place 2-way stopcock on
pressure transducer port, then attach 10mL syringe.
Open tubing pack, hang cardiotomy reservoir in holder.
Ensure arterial and venous lines are over the first barb on the corresponding connector within the snakeskin.
Check all pigtails and stopcocks for: cracks and tightness, then close. Ensure there is a dead-ender cap on all
stopcocks.
Route tubing as it will lie during ECMO. Remove all kinks/twists at this time.
Connect venous line to inlet of Better Bladder.
Connect raceway to bottom of Better Bladder, then route through raceway as it will lie during ECMO. Leave as much
raceway as possible on the outlet side of roller pump, this will accommodate a raceway walk in the future. Close
tubing locks over raceway (Do not place roller head on tubing). Connect free end to inlet of the oxygenator.
14.1. For the centrifugal circuit, connect the 4” 3/8 x3/32 piece of tubing to the bottom of the Better Bladder,
and then to the inlet of the centrifugal disposable pump. Next connect the tubing with the two 3/8
double luers to the outlet of the centrifugal disposable pump and the remaining end to the inlet of the
oxygenator. Place disposable centrifugal pump into drive unit
Connect arterial line to outlet of the oxygenator, route through and close bubble
detector around arterial line.
Connect oxygenator arterial outlet port to hemoconcentrator with tubing
from CDI pack. Then connect hemofilter outlet to pre-bladder parallel “Y”.
Connect arterial outlet stub with stopcock to CDI tubing with male-male
Bubble
adapter to another CDI tubing and connect to other pre-bladder parallel “Y”
Detector
(for CDI cuvette to be added later)
Connect waste line/s to the suction canister/s. Close Robert’s clamp.
Connect 6” pigtail with 3-way stopcock and 2’ line to both pre- and post-oxygenator pressure monitoring ports and
then to the corresponding pressure transducers (the above lines are part of each tubing pack).
Attach the 6” pigtail to the venous port on the outlet of the Better Bladder, then attach the 3-way stopcock to the 2’
line to. Then attach the 2’ line to the bladder transducer.
Connect parallel “Y’s” and 2-way stopcocks to the first and second connector post bridge and the pre-oxygenator
port. (described below on the circuit diagram.)
Connect the water lines to the oxygenator and ensure they are tightly connected to the Cincinnati Sub-Zero (CSZ)
Heater.
To connect the gas line with 0.2μicron filter: Cut off the luer connector, then connect the gas line to the inlet gas
port of the oxygenator. Next, cut the suction tubing and attach to the gas line 0.2μ filter. Finally, cut the free end of
the suction tubing so that it will reach the outlet (green pressure relief valve “Christmas Tree”) of the blender and
attach.
Set pressure transducer high and low limits. For limits refer to the NCH Jostra Prime Checklist.
13
24. Ensure roller pump is set to the proper tubing size with correct inserts, is in ‘arterial’ mode and is properly calibrated
(See calibration insert below).
25. Place (3) bottles of sterile H20 on the Jostra cart for future use in the CSZ heater.
26. Ensure hand-cranks, flashlight and additional tubing inserts are available in cart drawer.
27. Store pump with “Bullseye” on. The batteries on the Jostra cart will only charge in this configuration.
28. Record all information on the NCH Jostra Prime Checklist, display this on the cart.
ROLLER PUMP CIRCUIT DIAGRAM
14
CENTRIFUGAL PUMP DIAGRAM
15
ROLLER PUMP CALIBRATION
RPM’S
FLOW (L/min)
1/4
25
0.32
1/4
100
1.28
3/8
25
0.67
3/8
100
2.67
1/2
25
1.13
1/2
100
4.5
TUBING
16
Priming Matrix
Weight
Circuit
Raceway
Oxygenator
Circuit Connectors
Prime Volume
Surface Area
Min/Max blood flow
Max gas flow
Hemofilter
Max ultra rate
Pump calibration
Pump inserts
Pressure limits (mmHg)
Circuit Volume
Prime
Albumin to circuit
Blood
Add to each:PRBC / FFP
Drugs to Cardiotomy
Blender FiO2
Patient Heparin Bolus
VA ECMO
Arterial Cannula
Venous Cannula
Target Pump Flow
Full ECMO support
Idle =
Min. pump flow rate
Trial Off
VV ECMO
Double lumen
Cephalad Catheter
Dual Position
Neck (Arterial)
Groin
Full Flow
Idle
Trial Off
Walk raceway
Raceway (Super Tygon)
1 - 10 Kg
>10 - 20 Kg
>20- 30 Kg
> 30 Kg
1/4" x 1/4"
3/8" x 3/32"
Quadrox iD
1/4”
81 ml
0.8 m2
0.2 - 2.8 l/m
5.6 l/m
Terumo CX*HCO5S
50 ml/min
25 RPM = 670 ml/min
White
Bladder = -20 /100
Pre-Ox= -1 / 350
Post-Ox= -1 / 300
419 mL
1/4" x 3/8"
3/8" x 3/32"
Quadrox D / iD
3/8 "
250 ml
1.8 m2
0.5 - 7 l/m
> 15 l/m
Terumo CX*HCO5S
50 ml/min
25 RPM = 670 ml/min
White
Bladder = -20 /100
Pre-Ox= -1 / 350
Post-Ox= -1 / 300
718 ml
1/4" x 3/8"
Centrifugal
Quadrox D
3/8 "
250 ml
1.8 m2
0.5 - 7 l/m
> 15 l/m
Terumo CX*HCO5S
50 ml/min
Centrifugal
None
Bladder = -20 /100
Pre-Ox= -1 / 350
Post-Ox= -1 / 300
600ml
3/8" x 3/8"
Centrifugal
Quadrox D
3/8 "
250 ml
1.8 m2
0.5 - 7 l/m
> 15 l/m
Terumo CX*HCO5S
50 ml/min
Centrifugal
None
Bladder = -20 /100
Pre-Ox= -1 / 350
Post-Ox= -1 / 300
900 ml
50 ml of 25% (Recirc x 5
min)
50 ml of 25% (Recirc x 5
min)
50 ml of 25% (Recirc x
5 min)
50 ml of 25% (Recirc x 5
min)
2 unit PRBC / 1 unit FFP
/ 120mL PLT
300 units heparin/bag
800 mg CaCl
18 mEq of HCO3
20 ml of Tham
50 ml of 25% Albumin
21%
2 units PRBC / 2 unit
FFP
300 units heparin/bag
1100 mg CaCl
20 mEq of HCO3
30 ml of Tham
50 ml of 25% Albumin
21%
2 units PRBC / 2 unit
FFP
300 units heparin/bag
1100 mg CaCl
20 mEq of HCO3
30 ml of Tham
50 ml of 25% Albumin
21%
200 units per kg
200 units per kg
200 units per kg
200 units per kg
8 Fr - 12 Fr
10 Fr - 14 Fr
100-120ml/kg/min
150 ml/kg/min
20 ml/Kg/Min
500 ml/min
12 Fr-15 Fr, 17 Fr
12 Fr-15 Fr, 17 Fr
100-120 ml/kg/min
120 ml/Kg/min
20 ml/Kg/Min
500 ml/min
16 Fr or greater
19 Fr or greater
CI = 2.2
CI = 2.2
20 ml/Kg/Min
500 ml/min
VBA x 2hr Flash Q10min
VBA x 2hr Flash Q10min
12 Fr-15 Fr, 17 Fr
12 Fr-15 Fr, 17 Fr
CI = 2.2
CI = 2.2
20 ml/Kg/Min
500 ml/min
VBA x 2hr Flash
Q10min
See Manual
8 Fr -10 Fr
See Manual
10 Fr -12 Fr
See Manual
10 Fr -12 Fr
See Manual
14 Fr or Greater
N/A
N/A
120-140 ml/Kg/min
100 ml/min
12Fr or Greater
14Fr or Greater
120-140 ml/Kg/min
200 ml/min
15Fr or Greater
23Fr or Greater
CI = 2.2
500 ml/min
Isolate gas port x 30min
Isolate gas port x 30min
12Fr or Greater
14Fr or Greater
120-140 ml/Kg/min
200 ml/min
Isolate gas port x
30min
< 1,000,000 impacts
3/8 x 3/32
< 1,000,000 impacts
3/8 x 3/32
17
3 units PRBC / 2 unit FFP
300 units heparin/bag
1400 mg CaCl
25 mEq of HCO3
30 ml of Tham
100 ml of 25% Albumin
21%
VBA x 2hr Flash Q10min
Isolate gas port x 30min
2.2 Cardiac Index
2.2 Cardiac Index
2.2 Cardiac Index
1 - 17 Kg Patient
18 - 33 Kg Patient
34 - 50 Kg
1 Kg = 0.27 l/min
18 Kg = 1.61 l/min
34 Kg = 2.54 l/min
2 Kg = 0.36 l/min
19 Kg = 1.68 l/min
35 Kg = 2.59 l/min
3 Kg = 0.45l/min
20 Kg = 1.74 l/min
36 Kg = 2.64 l/min
4 Kg = 0.54 l/min
21 Kg = 1.80 l/min
37 Kg = 2.69 l/min
5 Kg = 0.63 l/min
22 Kg = 1.87 l/min
38 Kg = 2.73 l/min
6 Kg = 0.71 l/min
23 Kg = 1.93 l/min
39 Kg = 2.78 l/min
7 Kg = 0.79 l/min
24 Kg = 1.99 l/min
40 Kg = 2.83 l/min
8 Kg = 0.88 l/min
25 Kg = 2.05 l/min
41 Kg = 2.87 l/min
9 Kg = 0.96 l/min
26 Kg = 2.10 l/min
42 Kg = 2.92 l/min
10 Kg = 1.03 l/min
27 Kg = 2.16 l/min
43 Kg = 2.96 l/min
11 Kg = 1.11 l/min
28 Kg = 2.22 l/min
44 Kg = 3.00 l/min
12 Kg = 1.19 l/min
29 Kg = 2.27 l/min
45 Kg = 3.05 l/min
13 Kg = 1.26 l/min
30 Kg = 2.33 l/min
46 Kg = 3.09 l/min
14 Kg = 1.33 l/min
31 Kg = 2.38 l/min
47 Kg = 3.13 l/min
15 Kg = 1.40 l/min
32 Kg = 2.43 l/min
48 Kg = 3.17 l/min
16 Kg = 1.47 l/min
33 Kg = 2.49 l/min
49 Kg = 3.21 l/min
17 Kg = 1.54 l/min
50 Kg = 3.25 l/min
Cardiac Index = (4 x wt. in Kg x 7) / (90 + Kg)
Multiply above answer by 2.2 to find cardiac
index of 2.2 which may be considered full
support.
Circuit Crystalloid Prime
Personnel:
ECMO Primer
Perfusionist
Equipment:
Select appropriate dry circuit based on patient weight:
2-10Kg (1/4 x 1/4), >10-20Kg (1/4 x 3/8), 21-30Kg (1/4 x 3/8 Centrifugal), >30Kg (3/8 x 3/8 Centrifugal)
If appropriate dry circuit is unavailable, choose appropriate circuit/tubing pack and follow steps outlined in the
ECMO protocol “Circuit Assembly”.
1 or 2- 1000mL Normosol-R
Ultrafilter
o Terumo HCO5S
3- liters sterile H2O (CSZ heater)
*** SEE ROLLER PUMP CIRCUIT DIAGRAM BELOW ***
or
*SEE CENTRIFUGAL PUMP DIAGRAM BELOW*
18
Outcome:
Fully assembled sterile crystalloid primed ECMO circuit. This assembled circuit and corresponding pump
will be immediately available for patient use.
Goal: Once setup, the crystalloid primed ECMO circuit may be utilized for up to 30 days. It is therefore important to
check all expiration dates when priming the circuit, as all expiration dates must be greater than 30 days from the
date of priming.
Steps:
1. Verify expiration dates on all supplies.
2. Check integrity of circuit and all components.
3. Place a clamp in the following locations:
Outlet of cardiotomy reservoir Clamp 1
Inlet of oxygenator Clamp 2
4. Close stopcocks on bridge (off to circuit).
5. Spike the Normosol-R bag with one of the rapid infuser lines and empty volume into the cardiotomy reservoir.
Note: The 1/4 x 3/8 circuit or larger will require two 1 L bags of Normosol-R.
6. Remove the clamp located at the outlet of the cardiotomy reservoir (Clamp 1). Fill venous line to Clamp 2 and
remove any remaining air bubbles by walking them back to the cardiotomy reservoir.
7. Remove the de-airing cap (yellow) on the inlet side of the oxygenator. Next remove the clamp at the inlet of the
oxygenator (Clamp 2). Priming solution will fill the oxygenator and continue up the arterial line.
8. Individually open and prime each pressure transducer. Ensure each is completely air free, as air within this system
will dampen the pressure transmission from the circuit to the transducer. Once air free, zero all transducers (See
ECMO protocol Zeroing Pressure Transducers).
9. Open/prime the bridge and all remaining pigtails throughout the ECMO circuit. Close bridge off to circuit once
primed and air free.
10. Confirm that the Roberts clamp is in the CLOSED position on the waste line, and in the OPEN position on the arterial
line. Remove any additional clamps that may have been placed on the ECMO circuit.
11. Load raceway tubing into roller head at this time.
11.1. Invert disposable centrifugal pump so that outlet is in the highest position with respect to the ground.
Gently tap around outer edge to dislodge any remaining air within the system. Once air free, place
disposable centrifugal pump back into drive unit. Skip steps 12-14, 16, 17 for centrifugal setup.
12. Again place clamp at the inlet of the oxygenator (Clamp 2).
13. Set the roller head occlusion (see ECMO protocol Setting the Circuit Occlusion).
14. Remove clamp at the inlet of the oxygenator (Clamp 2).
15. Turn on Monitor (M button) and pump (P2 Button) power.
15.1. For centrifugal, turn additional power button on pump console to ON. After initial power up process, press
and hold ‘valve’ button for 3 seconds. Then press and hold ‘level’ button for 3 seconds.
16. Wait for internal check to complete, turn pump flow control knob up, then down.
17. Verify proper tubing ID and ART mode in the pump status window.
18. Confirm high and low limits for pre/post-oxygenator and bladder pressure limits.
19. Slowly increase pump flow to 500mL/min.
Note: Watch cardiotomy reservoir volume during this period. Stop pump and add more Normosol-R if level in
the cardiotomy reservoir falls below the manufacturer’s minimum level.
19
20. Allow pump to continuously recirculate at 500mL/min for at least 5 minutes through 0.2µicron filter.
21. Prime appropriate hemofilter and connect to the circuit (see ECMO protocol Ultrafiltration)
22. Fill Cincinnati Sub Zero (CSZ) heater with sterile H20 to full point, ensure water line shut off valves are open, turn on
CSZ. Visualize flow indicator function, confirm water level again, as it may have decreased with the displacement of
the air that remained in the water lines and the oxygenator. Set the temperature to 38.0 degrees.
23. Recirculation at a higher flow rate is acceptable at this point, and may aid in the removal of micro air as the number
of passes through the 0.2µicron pre-bypass filter increases.
24. Visually inspect the entire circuit for leaks or remaining air. Correct either at this time.
25. Once the circuit is air free, it is ready for patient use. At this time, the circuit may either be shut down and stored for
up to 30 days, or further prepared for patient use.
26. If the circuit is to be shut down, perform the following steps:
Turn off CSZ heater
Decrease pump flow to zero
Turn OFF pump power (P2 button)
Turn OFF monitor (M button)
Remove raceway from roller head (leave raceway tubing within insert and tubing lock)
o Leave disposable centrifugal pump in drive unit.
Ensure hand-cranks, flashlight and additional tubing inserts are available in cart drawer.
Store pump with “Bullseye” on. The batteries on the Jostra cart will only charge in this configuration.
Record all information on the NCH Jostra Prime Checklist, display this on the cart.
27. If placing this circuit on a patient at this time, see either ECMO protocol Blood Prime or EMERGENCY Prime for
Rapid Deployment.
20
ROLLERPUMP CIRCUIT DIAGRAM
21
CENTRIFUGAL PUMP CIRCUIT DIAGRAM
22
Circuit Blood Prime
Personnel:
ECMO Primer, Perfusionist
Equipment:
Select appropriate crystalloid primed circuit based on patient weight:
2-10Kg (1/4 x 1/4), >10-20Kg (1/4 x 3/8), 21-30Kg (1/4 x 3/8 Centrifugal), >30Kg (3/8 x 3/8 Centrifugal)
If appropriate wet circuit is unavailable, choose appropriate circuit/tubing pack and follow steps outlined in the
NCH ECMO protocols “Circuit Assembly and Crystalloid prime”.
Order blood products based on NCH ECMO Prime Matrix
Prepare medications based on NCH ECMO Prime Matrix for future addition to the cardiotomy reservoir
4- Tubing clamps
3-5 Hemotap valves
CDI 500™ arterial cuvette and calibrator
*** SEE ROLLER PUMP CIRCUIT DIAGRAM BELOW ***
or
*SEE CENTRIFUGAL PUMP DIAGRAM BELOW*
Outcome:
Fully assembled sterile blood primed ECMO circuit. This assembled circuit and corresponding pump will
be immediately utilized.
Goal: Once setup, the blood primed ECMO circuit will be utilized for up to 4 hours. It is therefore important to confirm
ECMO need when blood priming the circuit, as the circuit and its components will expire 4 hours after priming, if
not in use.
Steps:
1. Verify expiration date on crystalloid primed circuit.
2. Check integrity of circuit and all components.
3. Begin calibration of the CDI 500™ arterial cuvette, once calibration is complete, insert into ECMO circuit (follow NCH
ECMO Terumo CDI 500™ in-line blood gas monitor setup & management protocol for this process).
3.1. Skip steps 4 & 7 for centrifugal pump setup.
4. Load raceway tubing into roller head.
5. Turn on Monitor (M button) and pump (P2 Button) power.
5.1. After initial power up process, press and hold ‘valve’ button for 3 seconds. Then press and hold ‘level’ button for
3 seconds.
6. Wait for initial power up process, turn pump flow control knob up-down.
7. Verify proper tubing ID and ART mode in the pump status window.
8. Confirm high and low limits for pre/post-oxygenator and bladder pressure limits.
9. Confirm that the Roberts clamp is in the CLOSED position on the waste line, and in the OPEN position on the arterial
line. Remove any additional clamps that may have been placed on the ECMO circuit.
10. Slowly increase pump flow to 500mL/min.
Note: Watch cardiotomy reservoir volume during this period. Stop pump and add more Normosol-R if level in
the cardiotomy reservoir falls below the manufacturer’s minimum level.
23
11. Allow pump to continuously recirculate at 500mL/min.
12. Ensure water line shut off valves on the Cincinnati Sub Zero (CSZ) heater are open, turn on CSZ. Visualize flow
indicator function, confirm water level. Set the temperature to 38.0 degrees.
13. Recirculation at a higher flow rate is acceptable at this point, and may aid in the removal of micro air as the number
of passes through the 0.2µicron pre-bypass filter increases.
14. Visually inspect the entire circuit for leaks or air. Correct either at this time.
15. Once the circuit has been recirculated for at least 5 minutes, decrease the pump flow to zero.
16. Clamp above and below inferior connector on the 0.2µicron pre-bypass filter (see diagram below for proper clamp
placement. Clamps 1 & 2).
17. Disconnect arterial line from the 0.2µicron pre-bypass filter and connect the arterial line directly to the cardiotomy
reservoir, remove clamp from arterial line.
18. Increase pump flow to 500mL/min
*From this point forward, circuit will expire if not placed on patient within 4hrs. Approval of hematologist required for
extended use beyond the 4hrs*
19. Add 50mL of 25% albumin slowly to outside (unfiltered) port on cardiotomy reservoir and recirculate for 5 minutes.
20. Check blood products with another qualified person per NCH policy!
Then prepare the PRBC, FFP and platelets if applicable by closing then inserting a hemotap valve into each blood
product bag.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
Followed by adding 300 units of heparin to each bag and gently mixing by rocking back and forth.
Decrease the pump flow to zero.
Close CDI 500™ and hemofilter shunts.
Place a clamp on the arterial line above the waste line “Y” (Clamp 3 below).
Open the Robert’s clamp on the waste line, and vent the suction canister.
Slowly increase the pump flow while simultaneously watching the cardiotomy volume and confirming fluid
movement into the suction canister.
Once the cardiotomy volume is below 25mL, decrease the pump flow to zero, then place a clamp at the outlet of the
cardiotomy reservoir (Clamp 4).
Add PRBC & FFP & PLT (if applicable) to cardiotomy reservoir.
Remove the clamp below the cardiotomy reservoir (Clamp 4).
Increase the pump flow to 250mL/min.
Primer/Perfusionist judgment will determine when the crystalloid has been displaced from the circuit by the PRBC
and FFP. At which time, the clamp on the arterial line (Clamp 3) should be removed and the Robert’s clamp on the
waste line should be clamped simultaneously.
Ensure volume within cardiotomy reservoir is above manufacturer’s recommended minimum level. Increase the
pump flow to 500mL/min.
Open CDI 500™ and hemofilter shunts
Add all additional medication per NCH ECMO Prime Matrix.
Draw and run an Activated Clotting Time (ACT) per NCH ECMO Performing an Activated Clotting Time Test.
Turn the sweep gas flow on at 0.5-1 L/min with the FiO2 set at 21%.
Monitor the CDI 500™ during this time. Once the pCO2 is at 50mmHg, turn OFF sweep gas flow.
Allow the circuit to recirculate for an additional two minutes.
Then draw and send a whole blood battery which includes pH, pCO2, pO2, K+, iCa++ , Base Excess and Glucose.
(NCH ECMO Blood sample protocol) from the ECMO circuit to the blood gas lab. While drawing the blood
sample, hit the “store” key on the CDI 500™.
Calibrate the CDI 500™ as soon as the results are available.
24
36. Correct the parameters on the whole blood battery utilizing the following steps.
pCO2 – If high, turn on sweep gas flow and monitor pCO2 reading on the CDI 500™. Turn off sweep gas flow
once the pCO2 is less than 50mmHg.
iCa++- If low, add calcium chloride to achieve a 1mg/mL of blood product utilized for the ECMO circuit prime.
This will be accomplished by summing the blood products utilized, then subtracting the milligrams of
calcium chloride added initially. The answer is the milligrams of additional calcium chloride needed.
o Example:
675 mL PRBC in prime, 250 mL FFP in prime = 925ml blood product
Initial calcium chloride added to circuit 800mg
To correct:
925 (blood) – 800 (calcium chloride) = 125mg of calcium chloride needed.
Potassium (K+)- If high > 6mmol/L, treatment options include:
o Zero-Balance Ultrafiltration (Z-BUF) by addition of 0.9% normal saline (0.9% NaCl) or Normosol-R at
a rate of 999mL/hour while concurrently removing effluent via the hemofilter at a rate of
999mL/hour.
o Increasing the pH by adding Sodium Bicarbonate (NaHCO3) or blowing off more CO2 by turning the
sweep gas flow back ON for a period of time.
o If unable to accomplish the above step for lowering K+ concentration proceed by slow initiation
(remain at 20ml/Kg/min x 5-10 minutes)
Base Excess correction (BE)- If the BE is more than -4mEq/L then treatment may be warranted. To correct
the BE, follow the below steps:
o 1/4 x 1/4 circuit – 0.4mEq of NaHCO3 for every 1mEq/L of deficit.
o 1/4 x 3/8 circuit – 0.7mEq of NaHCO3 for every 1mEq/L of deficit.
o 3/8 x 3/8 circuit – 0.9mEq of NaHCO3 for every 1mEq/L of deficit.
o
Example:
1/4 x 1/4 circuit blood gas has a BE of -7mEq/L.
To correct:
0.4 x [7] = 2.8mEq of NaHCO3 added to cardiotomy reservoir.
37. After correcting the blood gas, add Platelets to cardiotomy and recirculate at 500mL/min x 5min if applicable.
38. The ECMO circuit is ready for patient use.
25
ROLLER PUMP CIRCUIT DIAGRAM
26
CENTRIFUGAL PUMP CIRCUIT DIAGRAM
27
EMERGENCY Prime for Rapid Deployment
Personnel:
ECMO Primer, Perfusionist
Note: The Emergency prime procedure is only to be used in cases where the patient needing ECMO is in cardiac arrest
or to replace a circuit that has acutely failed on an ECMO patient. In the above situations further delays may lead to
unfavorable sequela.
Equipment:
Select appropriate dry circuit based on patient weight:
o 2-10Kg (1/4 x 1/4) for this pre-primed circuit, skip to step #10.
o 11-20Kg (1/4 x 3/8)
o 21-30Kg (1/4 x 3/8 Centrifugal)
o >30Kg (3/8 x 3/8 Centrifugal)
1-2 1000mL Normosol-R
3- liters sterile H2O (CSZ heater)
*** Roller Pump Circuit and Centrifugal Pump Diagrams Below ***
Outcome:
Fully assembled sterile crystalloid primed ECMO circuit for immediate use.
Goal: Crystalloid primed ECMO circuit with medications added ready for use in 15 minutes or less.
Steps:
1. Verify expiration dates on all supplies.
2. Place a clamp in the following locations:
Outlet of cardiotomy reservoir Clamp 1
3.
4.
5.
6.
7.
8.
9.
10.
Inlet of oxygenator Clamp 2
Close stopcocks on bridge (off to circuit).
Spike one or both Normosol-R bags with one of the rapid infuser lines and empty volume into the cardiotomy
reservoir.
Remove the clamp located at the outlet of the cardiotomy reservoir (Clamp 1). Fill venous line to Clamp 2 and
remove any remaining air bubbles by walking them back to the cardiotomy reservoir.
Remove the de-airing cap (yellow) on the inlet side of the oxygenator. Next remove the clamp at the inlet of the
oxygenator (Clamp 2). Priming solution will fill the oxygenator and continue up the arterial line.
Individually open and prime each pressure transducer. Ensure each is completely air free, as air within this system
will dampen the pressure transmission from the circuit to the transducer. Once air free, zero all transducers (See
NCH ECMO protocol Zeroing Pressure Transducers).
Open/prime the bridge and all remaining pigtails throughout the ECMO circuit. Close bridge off to circuit once
primed and air free.
Confirm that the Roberts clamp is in the CLOSED position on the waste line, and in the OPEN position on the arterial
line. Remove any additional clamps that may have been placed on the ECMO circuit.
Load raceway tubing into roller head at this time.
28
10.1.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
Invert disposable centrifugal pump so that outlet is in the highest position with respect to the ground.
Gently tap around outer edge to dislodge any remaining air within the system. Once air free, place
disposable centrifugal pump back into drive unit. Skip steps 11-13, 16 for centrifugal setup.
Again place clamp at the inlet of the oxygenator (Clamp 2).
Set the roller head occlusion (30-45gtts in 15 seconds)
Remove clamp at the inlet of the oxygenator (Clamp 2).
Turn on Monitor (M button) and pump (P2 Button) power.
14.1. Turn on Rotaflow™ pump power switch (front panel of pump).
Wait for internal check to complete, turn pump flow control knob up, then down.
15.1. Push and hold the ‘valve’ button for 3 seconds. Then press and hold ‘level’ button for 3 seconds.
Verify proper tubing ID and ART mode in the pump status window.
Confirm high and low limits for pre/post-oxygenator and bladder pressure limits.
Increase pump flow to 500mL/min.
Fill Cincinnati Sub Zero (CSZ) heater with sterile H20 to full point, ensure water line shut off valves are open, turn on
CSZ. Visualize flow indicator function, confirm water level again, as it may have decreased with the displacement of
the air that remained in the water lines and the oxygenator. Set the temperature to 38.0 degrees.
After 2 minutes of recirculating at 500mL/min, decrease pump flow to zero.
Clamp above and below inferior connector on the 0.2µicron pre-bypass filter (see diagram below for proper clamp
placement. (Clamps 3 & 4).
Disconnect arterial line from the 0.2µicron pre-bypass filter and connect the arterial line directly to the cardiotomy
reservoir, remove clamp from arterial line (Clamp 4).
Increase pump flow to 1L/min. Recirculate at this flow rate until turning flow OFF and handing the lines up to the
surgical field.
Visually inspect the entire circuit for leaks or remaining air. Correct either at this time.
For each 1000mL of Normosol-R utilized to prime the ECMO circuit add the following medication to the outside
(unfiltered) port on the cardiotomy reservoir:
50mL of 25% albumin slowly
1000units of Heparin
200mg Calcium Chloride
25mEq Sodium Bicarbonate
26. Turn sweep gas flow on at 1 L/min with the FiO2 at 100% for two minutes.
27. Initiate per NCH ECMO Initiation protocol with the following exception.
Begin ECMO flow at 20mL/Kg/min. DO NOT increase flow for 2-5minutes. As the crystalloid displaces the blood,
oxygen delivery will be severely decreased. After 2-5 minutes, increase to full flow (see NCH ECMO Matrix).
Note:
Immediately after placing the patient on ECMO begin hemofiltering. This will require quickly priming and
installing the correct ultrafilter. As effluent is taken off the circuit, replace this with a balanced combination of
PRBC’s, FFP and Platelets.
29
ROLLER PUMP CIRCUIT DIAGRAM
30
CENTRIFUGAL PUMP CIRCUIT DIAGRAM
31
Pre-Bypass Filter Removal
32
Initiation of ECMO Flow
Personnel: ECMO Specialist, Primer or Perfusionist
Equipment: Blood primed ECMO Circuit
Personnel Protective Equipment (PPE)
Steps:
1. Apply PPE
2. Heparin Bolus (200units/Kg) administered to patient 3-5 minutes prior to cannulation.
a) Re-dose heparin 30 minutes after above dose, if not on ECMO. Dose will equal 100units/Kg.
b) Repeat 2a above until on ECMO.
3. Once the surgeon asks for the lines:
a) Decrease pump flow to 200mL/min and continue recirculating through CDI arterial and hemofilter shunts.
b) Place a clamp above the bridge on both the arterial and venous lines (see diagram Clamps 1 & 2)
c) Place a clamp above the snake skin on both the arterial and venous lines (see diagram Clamps 3 & 4)
d) Remove top tape holding snakeskin on the arterial line first
o Roll top of snakeskin over in such a manner as to keep the sterile side toward the tubing.
o Pull snakeskin down ~ 3” so the surgeon can grasp the tubing at the connector with a sterile clamp.
o Secure the top and bottom of the tubing on the non-sterile portions while the surgeon separates the
arterial line from the connector.
o Ask the surgeon to hold onto the tubing securely while the snakeskin is pulled the rest of the way down
the tubing.
o Watch the connection to the arterial cannulae in an effort to assist the surgeon and assuring that this
connection was air free.
 It is possible to now push volume up the arterial line if needed. Connect a 60mL syringe to the
ECMO circuit, turn the flow to zero, then remove the clamp above the bridge on the arterial
line, additionally have the surgeon remove their tubing clamp from the arterial line, push
volume into the circuit, then replace clamps and again recirculate at 200mL/min.
4. Repeat the above sequence (Step #3d) for the venous line.
5. Once the surgeon is ready, he/she will remove the clamps on the arterial and venous cannulae.
6. Remove the Arterial line clamp (Clamp 1), followed by removal of the Venous line clamp (Clamp 2).
7. Increase the pump flow to idle (20mL/Kg/min as viewed on the flow probe).
8. Attach the sweep gas flow line to the oxygenator and increase the sweep gas flow to a 0.5:1 ratio with the
blood.
Example:
If the current blood flow is 300mL/min, then set the sweep gas flow to 0.15L/min.
Follow CDI 500™ as a guide to adjust sweep gas flow and FiO2.
9. Gradually increase blood flow and sweep gas flow until “full flow” is reached (see NCH ECMO Matrix). This
should take 15 – 20 minutes, may be faster than 15-20 minutes in cardiac arrest applications.
33
10. Once on ECMO, cannulae position will be evaluated, after removing shoulder roll and returning head to midline
position, in one of the following manners:
Radiographically
Echocardiographically
Bridge Opening & Maintenance
Once on ECMO, if full flow is <500ml/min for the Quadrox D® or <300ml/min for the Quadrox iD® as set on the pump,
proceed with the following sequence.
1. Remove ‘snake skin’ from arterial and venous lines.
2. Apply flowprobe to arterial line above bridge, if not already placed.
3. Place Hoffman clamp on bridge in fully closed position.
4. Open stopcocks on both arterial and venous ends of bridge.
5. Slowly begin to open Hoffman clamp while increasing pump flow to maintain consistent blood flow delivery to
the patient. This bloodflow is read by the flowprobe.
6. Continue step #5 above until pump flow is ≥ 500ml/min or ≥ 300ml/min and flowprobe is reading prescribed
bloodflow rate.
7. Record pump flow, flowprobe bloodflow and circuit pressures changes in the patient medical record.
8. If bridge flushing is necessary, refer to Flushing Bridge with Crystalloid.
34
ECMO Circuit Diagram
With the initiation of ECMO the ECMO Specialist, Primer or Perfusionist may see the following patient conditions.
The below conditions and suggested resolutions are only suggestions and the ECMO physician will determine the
final course of action for each patient.
Hypovolemia:
Patients may become hypotensive secondary to hypovolemia during the initiation of ECMO. Hypovolemia can
result from adjustment to prime, bleeding, hemodilution and patient vascular dilatation. The hypovolemic
patient will not have sufficient right atrial volume to support full flow. Giving blood and/or volume (10-20
mL/kg) may correct hypovolemia. However, it is important to determine if the patient is truly hypovolemic prior
to volume administration. Other causes of inadequate venous return include:
o Inadequate venous cannula diameter.
o Excessive venous line length.
35
o Improper cannula position.
o Improper calibration/setting of bladder transducer limits
o Bed height
Fluid boluses should only be given after other causes of insufficient venous return, particularly those related to
the venous cannula, have been eliminated.
Hypertension:
Patients may also become hypertensive secondary to the vasopressor they were on prior to ECMO.
Hypertension may also be the result of inadequate pain control/sedation as the ECMO circuit will quickly
decrease the circulating levels of these medications. Increased frequency and larger doses of sedation are often
required for the ECMO patient. Ensure adequate sedation/pain control have been achieved prior to weaning
vasopressors. In the presence of adequate sedation/pain control, without vasopressor support hypertension
should be treated by vasodilator therapy ie. Nitroprusside, Nitroglycerin, Nicardipine, etc…
Arrhythmias
These may occur during the placement of the venous cannula or at the initiation of ECMO. These are often
the result of stimulation of the SA node by the cannula or from electrolyte imbalances, particularly iCa++and
K+. Corrections may include cannulae reposition and/or electrolyte treatment.
***May occur with crystalloid initiation, in which case the initiation should proceed more slowly allowing
better mixing of the crystalloid prime and patient blood. Immediate PRBC administration should be
considered.***
Ventilation
When the patient stabilizes on VA ECMO the ventilator settings may be decreased to “rest” settings. Cardiac
patients should remain on reasonable vent settings, and should not have their ventilator set to rest settings.
On V-V ECMO the ventilator FiO2 will be weaned over several hours. Moderate levels of ventilatory support
may be required throughout the ECMO run to achieve the desired level of patient support.
Emergency ventilator settings should be a written order within the patient’s medical record.
Full Flow
o Inotropes are weaned and usually discontinued on VA ECMO. On V-V ECMO inotropes are weaned
slowly. Some V-V patients may require inotropes throughout the entire run.
o On VA ECMO the arterial tracing must be watched closely as the pump flow is increased. The tracing
should begin to dampen as 100-150 ml/kg/min of flow is achieved. Monitoring of SvO2, base excess,
serum lactate and cerebral oximetry may be used as a guide for blood flow adequacy.
o Once the patient has been on ECMO for 5 minutes, an ACT should be checked. The heparin infusion is
started when the ACT drops to 225 seconds. The initial rate should be 20units/kg/hr. The initial ACT may
be high and can drop quickly. The ACT should be monitored every 15 minutes until stable within the
desired range. Titrate heparin according to NCH ECMO Heparin Infusion, Xa- Administration &
Management protocol. A full set of laboratory samples including coagulation tests, should be drawn
once the patient has reached the target flow.
o The circuit tubing should be securely anchored to the bed, tyband all tubing connections.
o Complete the ECMO initiation note in the patient’s medical record.
36
Removal From & Return to ECMO Support
Personnel: ECMO attending physican and ECMO specialist, primer, or perfusionist
Equipment: 2- tubing clamps
Goal: Removal/Return to ECMO support without incident
Outcome: Uneventful removal/return to ECMO support
Procedure: To come OFF ECMO electively for a planned procedure.
Steps:
1. Notify ECMO physician, perfusionist, bedside RN and respiratory therapist (RRT).
The perfusionist on call must be notified prior to electively removing a cardiac patient from ECMO.
2. Define the procedure:
Assign responsibilities.
Collect, assemble and flush/prime supplies if needed.
Rehearse the procedure with the team.
3. Increase ventilator settings or hand ventilate (RRT).
The cardiac ECMO patient should have been at full ventilation while on ECMO. There should therefore be no
reason to increase the ventilator settings at this point.
4.
5.
6.
7.
8.
9.
10.
Additionally, the cardiac ECMO patient may need Carbair or carbogen added to the sweep gas during ECMO.
(See NCH Blood gas management for the ECMO patient).
Pause the ultrafilter and all fluids going to the ECMO circuit.
Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO (Venous - Bridge - Arterial).
a. Venous- indicates clamping the venous line above the bridge.
b. Bridge- indicates opening of both stopcocks or Hoffman clamp, which allows blood to flow through the bridge.
c. Arterial- indicates clamping the arterial line above the bridge.
Remove sweep gas flow line from oxygenator.
Increase pump flow to 500mL/min.
Start timer to count time OFF ECMO.
Document procedure, date/time, action taken, patient’s response.
Procedure: To come OFF ECMO Emergently.
Note: Emergent removal from ECMO should be limited to the following situations:
1. Air in arterial line
2. Arterial cannulae dislodgement
3. Loss of circuit integrity
Steps:
37
1. Quickly decrease the pump flow to zero liters/min.
2. Remove patient from ECMO (Venous - Arterial).
Bridge clamping intentionally omitted.
3.
4.
5.
6.
7.
8.
9.
Remove sweep gas flow line from oxygenator.
Increase ventilator to Emergency settings or hand ventilate (RRT)
Place “STAT” call to primer or perfusionist and ECMO physician
Pause the ultrafilter and all fluids going to the ECMO circuit.
Open bridge and begin to recirculate at 500mL/min, if possible.
Resolve event leading to ECMO support removal, if possible.
Document procedure, date/time, action taken, patient’s response.
_______________________________________________________________________
Procedure: To return to ECMO support
Steps:
1. Decrease pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater), place patient back on ECMO (Arterial –
Bridge - Venous).
a. Arterial- indicates unclamping the arterial line above the bridge.
b. Bridge- indicates closing of both stopcocks or Hoffman clamp, which prevents blood from flowing through
the bridge.
c. Venous- indicates unclamping the venous line above the bridge.
2. Reattach sweep gas flow line to oxygenator.
3. Resume previous blood flow rate as read by the flow probe.
4. Return ventilator to previous non-emergency settings.
5. Using ECMO flush, attach 10ml syringe to the arterial-side bridge stopcock, turn venous-side bridge stopcock so it is
open to both the bridge and venous line, slowly flush bridge until clear of blood. Turn venous-side bridge stopcock
OFF to circuit. Place dead-ender caps on ALL open ports on bridge stopcocks.
6. Resume ultrafiltration and all fluid administration.
7. Perform a full circuit assessment.
8. Document procedure, date/time, action taken, patient response.
Weaning
Personnel: ECMO Specialist, ECMO attending physician
Equipment:
Blood flow meter and corresponding flow probe
Outcome: Controlled reduction in blood flow to the patient over a period of time until the patient is
at “idle”.
38
Idle is defined as:
VA ECMO: 20mL/Kg/min or 50mL/min (whichever is greater).
VV ECMO: 100mL/min for ¼ × ¼
200mL/min for ¼ × ⅜
500mL/min for ⅜ × ⅜ or larger circuits
Note: The decision to reduce the ECMO patient’s pump blood flow should be made after the ECMO physician has at a
minimum:
1) Reviewed the most recent chest X-ray.
2) Verified that the underlying disease leading to ECMO is resolving.
3) Is satisfied with the current ventilator regimen.
4) Considered a cardiac ECHO to rule out pulmonary hypertension and verify native cardiac function.
5) Reviewed the patient’s arterial and mixed venous blood gases.
The patient should not remain at “idle” for more than two hours before a trial off ECMO is conducted.
Steps:
1. Confirm physician order to wean pump flow.
The physicians order should include:
2.
3.
4.
5.
a. mL/hr or mL/Kg flow is to be weaned
b. Frequency of flow reduction, i.e. every hour
c. Patient blood gas parameters
d. Mixed venous (SvO2) parameters
e. New ventilator settings
f. Mean arterial pressure range
g. Lactate levels
Begin weaning the pump based on the above parameters.
The sweep gas will require manipulation during the weaning process, follow the CDI 500™ closely during
this period.
STOP weaning and notify the ECMO physician if not within the above parameters.
The minimum blood flow through the oxygenator is 500mL/min. If during the weaning process the blood
flow to the patient needs to be less than 500 mL/min:
a. While the bridge is still closed, place a Hoffman clamp on the bridge and close it completely
b. Open both stopcocks and verify absence of blood flow through bridge.
c. Place the flow probe on the arterial line above the bridge if not currently there.
d. Chart the current blood flow rate on both the flow meter and the pump. Chart the current pump
RPM’s.
e. Slowly open the Hoffman clamp
f. Watch the blood flow rate on the flow meter, increase the pump blood flow until the flow meter is
again reading the desired patient blood flow rate.
39
g. Chart the new pump blood flow rate and RPM’s as well as the flow meter blood flow rate.
6. Prior to trialing the patient off ECMO, move all medications from the circuit to the patient. See NCH
ECMO Protocol Trial Off ECMO.
Trial off
Personnel: ECMO Primer or Perfusionist, ECMO Physician
Equipment:
2- Tubing Clamps
Note: After a successful “idle” period, a trial off will generally be conducted. The trial off period will range from 30
minutes to several hours dependent upon the ECMO physician. The actual act of trialing a patient off ECMO will
vary depending on the type of ECMO they are on (VA vs. VV).
Goal: The trial off period is used to assess the adequacy of the patient’s cardiac and/or pulmonary function without
ECMO support.
Steps: Steps #1-3 below will be applied to both VA and VV ECMO patients.
1. Suction the patient’s airway 30 minutes prior to the trial period.
2. Verify the patient’s ventilator settings.
3. Activate and print three whole blood batteries (WBB= Arterial blood gas with electrolytes).
VA PATIENT
1.
2.
3.
4.
5.
6.
7.
8.
9.
Change all fluids from the ECMO circuit to the patient (including heparin @ current rate).
STOP ultrafiltration and replacement fluid
Wean pump flow to 20mL/Kg/Min or 50mL/min (whichever is greater).
Remove the patient from ECMO (Venous-Bridge-Arterial).
Start timer.
Disconnect sweep gas flow line from oxygenator and place on pump flow control knob.
Increase pump flow to 500mL/min.
Draw a WBB and ACT from the patient’s arterial line every 10 minutes x 3 (See Chart 1).
“Flash” the cannulae every 10 minutes AFTER the WBB/ACT have been drawn (See Chart 1).
To “flash” the cannulae:
a. Decrease the pump flow to 20mL/Kg/Min or 50mL/min (whichever is greater).
b. Place the patient back on ECMO (Arterial-Bridge-Venous).
c. Wait 20 seconds; ensure the blood within the cannulae and tubing has been exchanged, then again remove
the patient from ECMO (Venous-Bridge-Arterial).
d. Increase pump flow to 500mL/min.
10. If remaining off ECMO longer than 30 minutes, draw WBB per physician order or every hour.
11. Draw ACT as above from the patient. Additionally draw ACT’s every 15 minutes from the ECMO circuit. If remaining
off ECMO longer than 30 minutes, draw ACT’s every 30 minutes from the circuit and the patient (See Chart 1). Treat
circuit and patient ACT so they remain within ordered parameters.
12. Once the trial off is finished; place the patient back on ECMO as described above in cannulae flashing section,
increase pump flow to the prescribed flow rate, decrease ventilator settings, stop timer, place sweep gas flow line
40
back on the oxygenator, return fluids to ECMO circuit as required, resume ultrafiltration/replacement therapy and
document trial off in the patient’s medical record.
13. Flush bridge with crystalloid per “Flushing Bridge with Crystalloid” procedure if not flowing through bridge after trial
is complete.
Chart 1.
Time off
(minutes)
10
15
20
30
40
50
60
90
120
WBB
√
ACT
patient
√
ACT
circuit
Flash
cannulae
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
VV PATIENT
1. Wean pump flow to “idle” (100mL/min for ¼ × ¼, 200mL/min for ¼ × ⅜ and 500mL/min for ⅜ × ⅜ or larger
circuits).
2. Disconnect sweep gas flow line from oxygenator and place on pump flow control knob.
3. Cap both the gas inlet and the gas outlet on the oxygenator.
4. Start timer.
5. Draw a WBB from the patient’s arterial line every 10 minutes x 3.
6. If remaining off ECMO longer than 30 minutes, draw WBB per physician order or every hour.
7. Draw ACT’s every hour unless ordered more frequently.
Once the trial off is finished; remove BOTH caps from the gas inlet and outlet on the oxygenator, place sweep gas flow
line back on the oxygenator, increase pump flow to the prescribed flow rate, decrease ventilator settings, stop timer and
document trial off in the patient’s medical record.
Flushing Bridge with Crystalloid
Equipment:
4ea Alcohol wipes
4ea 5ml ECMO flushes
1ea 20mL syringe
2ea steri-cap
Steps:
1. Apply PPE
2. Using the appropriate sampling port and aseptic technique, vigorously scrub arterial and venous stopcock/cap
interface with alcohol prep pad for 15 seconds followed by wiping interface with second alcohol prep pad, then
allow to dry for 30 seconds.
3. Remove solid, closed cap from arterial-side/venous-side stopcock.
41
4. Place 5mL ECMO flush syringe on arterial bridge-side stopcock, place empty 20mL syringe on venous-side
stopcock, open venous-side stopcock to syringe (remains off to circuit).
5. Open arterial-side stopcock (remains off to circuit), proceed with flushing forward toward the venous
stopcock/syringe with 5ml ECMO flush. If line still contains blood, repeat #4 and 5.
6. After bridge is cleared, turn arterial-side and venous-side stopcock OFF to syringes and circuit. Remove 20mL
and 5mL syringes.
7. Attach solid, closed steri-caps to replace 5ml and 20mL syringes on arterial side & venous side stopcocks.
Cannulae Stenting Procedure
Personnel: ECMO Primer or Perfusionist
Equipment:
Luered perfusion adapter (available in ¼” and 3⁄8” only)
2Ft pressure tubing and 2ea two-way stopcocks or Medfusion tubing
Betadine prep (bottle)
4- tubing clamps
Sterile scissors
Sterile towels
Sterile gown and gloves
Personnel Protective Equipment (PPE)
500mL arterial line flush from pharmacy (concentration 2 units Heparin/ml)
Outcome: Patent arterial and venous cannulas in the event the patient needs to be returned to ECMO support. Stenting
the cannulas will allow rapid replacement of ECMO support in the event of acute patient failure.
Goal: Maintain patency of both the arterial and venous cannulae
Steps:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Verify physician order to remove patient from ECMO support.
Gather supplies (see above)
With attending physician present:
The ECMO primer or the perfusionist will bring the pump flow to idle (20mL/Kg/min).
The ECMO primer or the perfusionist will then clamp the patient off ECMO.
Recirculate the pump once disconnected at a rate of 500mL/min.
Disconnect gas flow from the oxygenator.
Double clamp the arterial and venous lines.
In a sterile fashion betadine prep the area between the clamps on each limb of the circuit. Then wipe w/ alcohol
pad x 2
Using sterile scissors, cut in between the two clamps on each line.
Insert the perfusion adapter or the ½” luered straight connector to each limb of circuit.
Remove all tubing clamps.
Aspirate back to remove all air within the cannula and connector.
Flush cannulae with an appropriate amount of 2unit/mL heparin solution to displace blood within the cannulae.
42
15. Preparation for one of the following three options should preceed separation of the patient from the ECMO
circuit.
CONTINUOUS INFUSION
ECMO primer or the perfusionist will aspirate back on the cannula to displace the crystalloid solution with blood.
They will then infuse a like amount of the above 2unit/mL solution, attach IV tubing primed with the heparin
drip to each of the perfusion adapters. Begin heparin (2 unit/mL) infusion at a rate of 5 mL per hour.
INTERMITTANT FLUSH
Alternately, the physician may choose to intermittently flush the cannula with a heparin (20unit/mL) solution
once per hour.
o To perform this, the ECMO primer or the perfusionist will aspirate back on the cannula to displace the
crystalloid solution with blood. They will then infuse a like amount of the above 20unit/mL solution.
HEPARIN LOCK
The final alternative will be a heparin locked cannula in which the cannula is flushed with a heparin
(100unit/mL) solution. This procedure should be performed every eight hours.
o To perform this, the ECMO primer or the perfusionist will aspirate back on the cannula to displace the
crystalloid solution with blood. They will then infuse a like amount of the above 100unit/mL solution.
Removal from ECMO support
Personnel: ECMO Primer or Perfusionist, ECMO Specialist, ECMO Physician
Equipment:
Personnel Protective Equipment (PPE)
4- Sterile tubing clamps
1- Sterile scissors
2- Sterile blue towels
2- Sterile gloves
Betadine Bottle
4-8 Sterile 4×4’s
Appropriate sized sterile connector (¼ × ¼ / ¼ × ⅜ / ⅜ × ⅜)
ECMO flush
Outcome: Elective removal from ECMO support.
Steps:
1. Ensure all fluids (excluding heparin and replacement fluid) are going to the patient.
2. Verify ventilator settings.
43
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Stop ultrafiltration/replacement fluid.
Apply PPE and sterile gloves.
Drape current Arterial and Venous lines with blue towels and prep lines with betadine soaked sterile 4×4’s.
Decrease pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO, (Venous-Bridge- Arterial) done by primer/perfusionist with sterile clamps within
the betadine prepped area.
Disconnect the sweep gas flow line from the oxygenator.
Increase the pump flow to 500mL/min.
Squeeze the arterial line and apply a second clamp to the line ~ 3” from the previous clamp. Repeat for the
venous line.
Using the sterile scissors, cut between each pair of tubing clamps.
Insert the straight connector into the tubing attached to either the venous or arterial cannulae, fill the connector
with ECMO flush in a sterile fashion, then connect to the remaining tubing in an air free manner.
Move the pump and circuit to the hallway and allow pump to recirculate through the bridge while the surgeons
complete the decannulation process.
Once the patient has been decannulated, the ECMO Specialist can remove and discard the circuit, clean all
reusable equipment and restock the bedside cart.
Document:
Procedure performed
Date and time off
Patient’s response
Any complications
Terumo CDI 500™ in-line blood gas monitor setup & management
Personnel: ECMO Specialist, Primer or Perfusionist
Equipment:
CDI 500 monitor
CDI 500 arterial cuvette
CDI 500 venous cuvette (built into sterile ECMO pack/ additional separate
sterile venous cuvettes are available in the ECMO equipment room)
CDI Tubing pack
Male-male connector
Calibrator module with A/B gases
Outcome:
Maintain patient arterial blood gas and venous hemoglobin/hematocrit/SvO2 parameters within
ordered/acceptable ranges as defined by the patient condition and specified by the physician order.
Goal Range: Arterial: pH 7.35-7.45, pCO2 35-45mmHg, pO2 100-300mmHg, K+ 3.5-5.5mmol/L. Venous: Hemoglobin 1215g/dl, hematocrit 35-45%, SvO2 > 60%. Or as ordered per attending physician.
Steps: Assembly and calibration (arterial only)
44
1. Plug monitor into wall outlet or alternative power source (monitor will not calibrate in battery use mode), turn
monitor ON and wait for internal calibration to complete with cables heads still attached.
2. Select proper monitoring parameter screen: #3- arterial abg;venous hgb/hct/SvO2.
3. ARTERIAL: Next, select ‘calibration’, plug in calibrator cable to rear of monitor, attach arterial cuvette to arterial
cable head, verify arterial cuvette K+ calibration number, remove blue cap from filter, loosen large blue cap on
top of cuvette, apply to calibrator gas assembly, start calibration. This will take 10mins to complete.
4. Remove cable head/cuvette from calibrator, close large blue port and cap filter.
5. IMPORTANT: Before adding to ECMO circuit, remove filter. If this step is omitted, blood will not flow through
sensor.
6. Attach male CDI cuvette end to the female end of CDI extension line air-free. Next, attach female CDI cuvette
end to male-male connector with CDI extension line. Attach a syringe filled with saline to this female end. Push
saline through both CDI lines and the cuvette to displace all air. Then connect male end of CDI tubing air-free to
the female-1/4 tubing stub with stopcock post-oxygenator, finally attach to venous pigtail port air-free.
7. Once attached and air-free, the Transonic™ flowprobe must be placed distal to this shunt (above bridge) to
provide a proper reading of cardiac output being delivered to patient. Open both pre/post sensor stopcocks to
start blood flow through sensor. Increase pump flow so that flowprobe
reading remains the same after opening shunt.
8. VENOUS: The venous cuvette does not need a calibration before
placement into the ECMO circuit. Place venous cable into venous
cuvette clip and monitor readings.
9. Once on ECMO, pre-oxygenator and post-oxygenator blood gases are
required for an additional calibration of the CDI 500TM. These should be
drawn within 15mins of initiation of ECMO. Remember to ‘store’ values
on the monitor when withdrawing sample. This will store the values at
the draw time for correlation to the blood samples when the results arrive.
10. Once results arrive, hit ‘recall’ then plug in appropriate values, finally hit the ‘checkmark’ button to resume
monitoring.
CORRECTIVE ACTIONS FOR “OUT OF RANGE” :
Parameters
pH
pCO2
pO2
K
SvO2
Hgb/Hct
Low
Low
Low
Low
Low
Low
Action
sweep

*↓
sweep
FiO2

‡
pH
Pump flow

Hgb

High
High
High
High
High
High
↓

↓

↓
Action
sweep
sweep
FiO2
pH
Pump flow
*May add carbair (5%CO2/21%O2) or carbogen (5%CO2/95%O2)
‡ Do not decrease pH below 7.35 or below physician's order.
45
Trouble shooting:
1.
2.
3.
4.
Temperature drop (<35.5C)- aspirate blood from arterial cuvette. Clot may be present, replace if necessary.
Leaking cuvette- tighten connection. If cracked, replace cuvette.
Values suspect after multiple calibrations- replace cuvette/monitor.
Minimum blood flow through arterial cuvette is 100ml/min and venous cuvette is 35ml/min for accurate
readings.
Document:
Procedure performed
Reason for changeout
Any complications
Patient’s response
Blood Gas Management for the ECMO Patient
Personnel: ECMO specialist, primer or perfusionist
Note:
These are general guidelines. Refer to ECMO physician orders for actual patient parameters.
These guidelines are for patients that have relatively normal cardiac anatomy without significant shunts. The
procedure for managing these patients should be discussed with the ECMO physician.
General ECMO parameters:
VA ECMO
V-V ECMO
SvO2
65-80%
Trending
SaO2
>90%
85-90%
Patient paO2
80-150 mmHg
40-60 mmHg
Patient paCO2
35-45 mmHg
35-45 mmHg
150-250 mmHg
150-250 mmHg
Post-membrane pO2
* Consider sighing the oxygenator in the presence of an increasing CO2 and decreasing PO2 despite sweep gas
changes.
Steps:
Verify ventilator settings against physician orders.
Monitor and assess condition of ECMO circuit.
Send pre & post-membrane gases every 12 hours to assess membrane function, calibrate CDI 500™ with these
results. Always obtain patient arterial blood gas at this time. Label gases appropriately.
46
Monitor and assess patient response to changes.
Change pump flow, sweep flow and FiO2 to maintain patient within ordered parameters.
For Veno-Arterial (VA) ECMO: Monitor CDI 500 ™ during all adjustments
a) If post membrane paO2 is greater than ordered parameters decrease FiO2 10% every 10 minutes until within
parameters.
Example: FiO2 set at 50% on blender, and PaO2 is out of range high.
Decrease FiO2 on blender to 40%.
b) If post membrane paO2 is less than ordered parameters increase FiO2 10% every 10 minutes until within range.
Example: FiO2 set at 50% on blender, and PaO2 is out of range low.
Increase FiO2 on blender to 60%.
c) If the patient PaCO2 is greater than ordered parameter and the pH is less than the ordered parameter, then
sweep gas flow should be increased based on the following calculation until within range. If there is question of
oxygenator function, refer to protocol for “sighing” the membrane lung.
PaCO2 x Sweep gas flow rate (L/min) = New sweep gas flow rate
PaCO2 desired
Example
Pt blood gas: pH 7.25, PaCO2 60, PaO2 150, sweep gas flow rate 0.42 L/min
60mmHg x 0.42L/min = 0.63L/min
40mmHg
d) If the patient PaCO2 is greater than ordered parameter and the pH is within the ordered parameter, then notify
the ECMO attending physician.
e) If the patient PaCO2 is less than ordered parameter then sweep flow should be decreased based on the above
formula until within range. Do not reduce sweep below 0.1L/min.
f) If sweep gas flow is at the minimum sweep gas flow of 0.1L/min and paCO2 is still less than ordered parameters,
Carbair (5% CO2/21% O2) or Carbogen (5% CO2/95% O2) may be utilized at 0.1L/min as a starting gas flow.
Caution: When using Carbair, close attention to circuit and patient PaO2 is needed, since less O2 may be delivered
due to diluting out FiO2 setting with 21% O2. The CDI 500™ should give ‘real-time’ data as to the changes being
administered.
ALWAYS use an in-line oxygen analyzer to monitor percent O2 being delivered to oxygenator with Carbair or
Carbogen use. Consider checking a patient ABG 30 minutes after adding Carbair or Carbogen.
g) Notify ECMO physician for patient ABG’s consistently outside ordered parameters.
For Veno-Veno (V-V) ECMO:
a) Same as above but SvO2 is used for trending only as it does not reflect the actual value due to recirculation.
b) The position of the dual lumen VV cannula may need to be changed to maximize oxygenation and reduce
recirculation. This is usually performed with the assistance of a cardiac ECHO in the presence of the ECMO
attending physician or surgeon.
47
Note: Cannulae/patient position should not be changed without an ECMO attending/surgeon present.
Documentation:
Lab results – patient, pre & post-membrane
Pump flow & sweep flow when gases drawn
SvO2 and SaO2 when gasses drawn
Interventions taken in management of ABG’s recorded on ECMO flowsheet
“Sighing” the Oxygenator
Personnel: ECMO Specialist
Equipment:
None
Outcome: Return/opening of gas channels within the hollow fiber oxygenator by removing excess condensation within
the oxygenator when at very low sweep flow rates.
Note: Do not “SIGH” the oxygenator without first discussing process and goal with an ECMO primer and/or a
Perfusionist.
The oxygenator should not be “sighed” unless there is evidence of decreased efficiency.
Steps for Quadrox D:
1. Note current readings on CDI 500TM regarding; PaCO2, PaO2 and pH.
2. Increase sweep gas flow rate to 15 L/min for 10 seconds. Watch for condensation exiting the oxygenator via the gas
exhaust port.
3. Return sweep gas to previous setting.
4. Monitor PaCO2, PaO2 and pH on the CDI 500TM very closely for the next 15-30 minutes.
5. During this post “sigh” period the PaCO2 may fall abruptly, compensation for this will be accomplished by weaning
the sweep flow rate based on the following formula.
Steps for Quadrox iD:
1. Note current readings on CDI 500TM regarding; PaCO2, PaO2 and pH.
2. Increase sweep gas flow rate to 5.6 L/min for 10 seconds. Watch for condensation exiting the oxygenator via the gas
exhaust port.
3. Return sweep gas to previous setting.
4. Monitor PaCO2, PaO2 and pH on the CDI 500TM very closely for the next 15-30 minutes.
5. During this post “sigh” period the PaCO2 may fall abruptly, compensation for this will be accomplished by weaning
the sweep flow rate based on the following formula.
PaCO2 (current) x sweep flow (L/min)(current) = New sweep flow rate in L/min
PaCO2 (desired)
48
Examples:
1)
Patient PaCO2 27mmHg, sweep gas flow rate 0.24 L/min. Desired PaCO2 40 mmHg.
27 x 0.24 = 0.162 L/min
40
2) Patient PaCO2 34mmHg, sweep gas flow rate 4.8 L/min. Desired PaCO2 40 mmHg.
34 x 4.8 = 4.08 L/min
40
Oxygenator Failure Diagnosis
Personnel: ECMO specialist, primer or perfusionist
Equipment:
Oxygen E cylinder
Green barbed pop-off connector (Christmas tree)
Oxygen supply tubing
Goal: Verification of oxygenator performance/failure
Normals:
Pre CO2 minus Post pCO2 = ~ 8 – 10 mmHg
Follow trends over previous days ABG’s for a more definitive diagnosis for each specific patient.
Steps:
1.
2.
3.
4.
Notify ECMO attending physician of potential oxygenator failure.
Verify air and O2 lines are connected securely to high pressure gas sources.
Verify sweep gas flow rate setting on blender/flowmeter.
Assure green barbed pop-off connector (Christmas tree) is tightly attached to blender
a. Assess proper function of barbed connector, replace if uncertain.
b. Confirm gas line is securely connected to both the green barbed connector and the oxygenator
Note: If one of the above steps is utilized to correct the problem, then perform pre/post oxygenator blood gases
within 5 minutes to asses oxygenator function. If this does not resolve the problem, continue to steps below.
5. Connect oxygen E cylinder via oxygen supply tubing directly to oxygenator gas inlet port, utilize the same
sweep gas flow rate currently in use.
6. Perform pre/post oxygenator blood gases within 5 minutes to asses oxygenator function.
7. If the above steps do not resolve the problem, consider:
a. Increasing ventilator settings
b. Perform oxygenator changeout (See NCH ECMO Quadrox D™ membrane oxygenator set up, prime and
changeout protocol)
49
Drawing a Blood Sample
Personnel: ECMO Specialist
Equipment:
PPE
Sterile 3 mL syringe or appropriate size for lab to be drawn
3ea Alcohol prep pads
5mL ECMO flush syringe or 3mL empty syringe
Necessary labels or laboratory vacutainer
Outcome:
Removal of a blood sample that is representative of the patients/circuits current status.
Note: Always ensure the sample that is about to be drawn is coming from the appropriate spot within the ECMO circuit
i.e post-oxygenator for an arterial sample.
Additionally, the circuit is at times under very negative or extremely positive pressure. It is imperative you
understand which type of pressure you will be subject to prior to entering the ECMO circuit.
Steps:
1. Apply PPE
2. Using the appropriate sampling port and aseptic technique, vigorously wipe stopcock/syringe interface with
alcohol for 15 seconds, wipe stopcock/syringe interface with second alcohol pad and allow to dry for 30 seconds.
3. Open stopcock & use 3mL luered syringe (in place prior to beginning blood draw) to remove 1mL of waste from
the circuit. Close stopcock.
4. Discard waste syringe into biohazard container.
5. Attach 3mL or appropriate syringe, open stopcock & withdraw quantity of blood needed. Close stopcock.
6. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
7. Attach new 5mL ECMO flush syringe, open stopcock & flush pigtail/port with 1mL of ECMO flush or attach empty
3mL syringe to stopcock.
8. Label syringe or vacutainer with :
Patient laboratory label
Employee number
Date drawn
Time drawn
Source
Venous Blood Sampling
Bridge closed
1. Refer to fully assembled circuit diagram for location of venous sample port.
2. Apply PPE
3. Using the appropriate sampling port and aseptic technique, vigorously wipe stopcock/syringe interface
with alcohol for 15 seconds, then wipe stopcock/syringe interface with second alcohol pad and allow to
dry for 30 seconds.
50
4. Open stopcock & use 3mL luered syringe (in place prior to beginning blood draw) to remove 1mL of
waste from the circuit. Close stopcock.
5. Discard waste syringe into biohazard container.
6. Attach 3mL or appropriate syringe, open stopcock & withdraw quantity of blood needed. Close
stopcock.
7. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
8. Attach new 3mL syringe
9. Label syringe or vacutainer with :
Patient laboratory label
Employee number
Date drawn
Time drawn
Source
Bridge Open
1. Refer to fully assembled circuit diagram for location of venous sample port.
2. Apply PPE
3. Slowly close Hoffman clamp fully on bridge while reducing pump flow to maintain consistent blood flow
delivery to the patient.
4. Wait a minimum of 30 seconds before drawing venous sample.
5. Using the appropriate sampling port and aseptic technique, vigorously wipe stopcock/syringe interface
with alcohol for 15 seconds, wipe stopcock/syringe interface with second alcohol pad and allow to dry
for 30 seconds.
6. Open stopcock & use 3mL luered syringe (in place prior to beginning blood draw) to remove 1mL of
waste from the circuit. Close stopcock.
7. Discard waste syringe into biohazard container.
8. Attach 3mL or appropriate syringe, open stopcock & withdraw quantity of blood needed. Close
stopcock.
9. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
10. Attach new 3mL syringe
11. Label syringe or vacutainer with :
Patient laboratory label
Employee number
Date drawn
Time drawn
Source
12. Slowly begin to open Hoffman clamp while increasing pump flow to maintain consistent blood flow
delivery to the patient. This bloodflow is read by the flowprobe.
13. Continue until pump flow is ≥ 500ml/min and flowprobe is reading prescribed bloodflow rate.
51
Component Changeout
ECMO Circuit Changeout
Personnel:
ECMO Primer, Perfusionist, ECMO attending physician
Equipment: See Non-emergent vs. Emergent below
Non-EmergentBlood primed ECMO circuit (see NCH ECMO Circuit Blood Prime)
Personnel Protective Equipment (PPE)
2- Sterile scissors
10- Sterile Clamps
Betadine Bottle
4-8 Sterile 4×4’s
4pr- Sterile gloves
3-4 sterile towels
2- 60mL syringes
2- Cath tip adapters
1- 1000mL bag NaCl
2- ¼ × ¼ straight connectors or 2- ⅜ × ⅜ straight connectors or 1- ¼ × ¼ straight connector and 1- ⅜ × ⅜
straight connector
Outcome: Replacement of the failing ECMO circuit.
Goal: Air free connection of a new ECMO circuit in the absolute minimum time off ECMO. This will be accomplished by
having a well laid out plan prior to clamping the patient off ECMO.
Note: Timing of the circuit changeout should be weighed against the possibility of coming off ECMO. If decannulation is
expected in the next 12-24 hours, it may be beneficial for the patient to remain on the current ECMO circuit until
that time.
The ECMO circuit changeout has the potential for catastrophic sequela. Therefore, the benefits of changing the
circuit must out-weight these potential sequela that include but are not limited to; infection, delivery of air or
plastic to the patient, exsanguination, cardiac arrest and accidental decannulation.
Additionally, circuit changes should be performed during day shift if at all possible when the highest numbers of
resources are available.
Steps: NON-EMERGENT
1. ECMO Physician at bedside.
52
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Prepare circuit as described in NCH ECMO Crystalloid/Blood prime.
Confirm ACT and Whole Blood Battery results on new circuit.
Ensure new circuit is at the proper temperature.
Apply PPE and sterile gloves.
Drape current Arterial and Venous lines with sterile towels and prep lines with betadine soaked sterile 4×4’s.
Remove and replace sterile gloves.
Move new ECMO pump to right side of current pump. Plug in; power to red outlet, air and O2 lines.
Draw NaCl into both 60mL syringes, and then apply cath tip adapters to each syringe aseptically, for use during
de-airing. (Assign one person to the role of fluid dispenser during the connection of the arterial and venous
lines).
Consider placing the patient on emergency ventilator settings.
Consider drawing extra prime volume out of the new circuits cardiotomy reservoir for volume boluses to patient
during the changeout.
Consider patient sedation and paralysis.
Assign one primer/perfusionist to cut-then connect either the arterial or venous line. They should then take
their appropriate positions next to the line they will be working on.
Open the bridge on the new circuit. Place clamps 1- 4 as in the diagram below.
Have the bedside ECMO specialist peel back the snakeskin in a sterile fashion so that each primer/perfusionist
can clamp the line at its separation point (clamps 5 & 6 in diagram).
Disconnect each line and bring onto sterile field. It may be necessary to remove some of the extra length within
these lines once the proper length has been determined.
Insert the appropriate straight connectors into the new arterial and venous lines.
Prepare to clamp the patients’ arterial and venous lines.
Pause the ultrafilter and all fluids going to the ECMO circuit.
Quickly decrease the pump flow to 20mL/Kg/minute.
Remove patient from ECMO, Clamp Venous & Arterial line (clamps 7 & 8 in next diagram) done by
primer/perfusionist with sterile clamps within the betadine prepped area.
The ECMO specialist must concurrently STOP arterial pump.
19. Squeeze the arterial and venous line within prepped area, then apply the second clamps (clamps 9 & 10) to each
line ~ 3” from the previous clamp.
20. Cut in between clamps leaving enough room to insert the straight connectors. Fill connectors and tubing with
NaCl ensuring this is an air-free connection to a depth of two barbs on each connector.
21. Reconfirm both connections are air-free.
It is essential that the Arterial connection be air-free. A small amount of air within the venous
connection can be removed from the circuit if using a roller pump as described in the NCH ECMO Air
Removal protocol.
22.
23.
24.
25.
26.
27.
28.
Decrease new pump flow to idle. When at idle, place patient back on ECMO (Arterial – Bridge - Venous).
Connect sweep gas to oxygenator and titrate based on CDI 500™
Resume previous flow rate as read by the flow probe.
Return ventilator to previous settings.
Resume ultrafiltration.
Change all drips from old circuit to new circuit.
Connect new heparin bag, and follow NCH ECMO Heparin infusion, Xa- Administration & Management
protocol.
* Trace heparin infusion to patient to ensure connection
53
29. Tyband all connections.
30. Document procedure in patient medical record
EmergentPrepare circuit as described in NCH ECMO EMERGENCY Prime for Rapid Deployment
Personnel Protective Equipment (PPE)
1- Sterile scissors
6- Sterile clamps
1pr- Sterile gloves
60mL ECMO flush syringe
Alcohol Prep pads
2- ¼ × ¼ straight connectors or 2- ⅜ × ⅜ straight connectors or 1- ¼ × ¼ straight connector and 1- ⅜ × ⅜
straight connector
Steps: EMERGENT
Note: The Emergency prime procedure is only to be used in cases where the patient needing ECMO is in cardiac arrest
or to replace a circuit that has acutely failed on an ECMO patient. In the above situations further delays may lead to
unfavorable sequela.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
ECMO Physician at bedside.
Prepare circuit as described in NCH ECMO EMERGENCY Prime for Rapid Deployment
Ensure new circuit is at the proper temperature.
Apply PPE and sterile gloves.
Drape current Arterial and Venous lines with sterile towels and prep lines with betadine pads x 2
Move new ECMO pump to right side of current pump. Plug in; power to red outlet, air and O2 lines.
Assign one person to the role of fluid dispenser during the connection of the arterial and venous lines. They will
utilize the 60mL ECMO flush syringes to facilitate these connections.
Place the patient on emergency ventilator settings.
Assign one primer/perfusionist to cut-then connect either the arterial or venous line. They should then take
their appropriate positions next to the line they will be working on.
Stop recirculation of new pump.
Have the bedside ECMO specialist peel back the snakeskin in a sterile fashion so that each primer/perfusionist
can clamp the line at its separation point (clamps 1 & 2 in EMERGENT diagram).
Disconnect each line and bring onto sterile field.
Insert the appropriate straight connectors into the new arterial and venous lines.
Prepare to clamp the patients’ arterial and venous lines.
Pause the ultrafilter and all fluids going to the ECMO circuit.
Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO, Clamp Venous & Arterial line (clamps 3 & 4 in EMERGENT diagram) done by
primer/perfusionist with sterile clamps within the alcohol prepped area.
54
The ECMO specialist must concurrently STOP arterial pump.
15. Squeeze the arterial and venous line within prepped area, then apply the second clamp (clamps 5 & 6) to each
line ~ 3” from the previous clamp.
16. Cut in between clamps leaving enough room to insert the straight connector. Fill connectors and tubing with
NaCl ensuring this is an air-free connection to a depth of two barbs on each connector.
17. Reconfirm both connections are air-free.
It is essential that the Arterial connection be air-free. A small amount of air within the venous
connection can be removed from the circuit if using a roller pump as described in the NCH ECMO Air
Removal protocol.
18. Place patient back on ECMO (Arterial – Bridge - Venous).
19. Connect sweep gas to oxygenator and titrate based on CDI 500™
20. Begin ECMO flow at 20mL/Kg/min. DO NOT increase flow for 2-5minutes. As the crystalloid displaces the blood,
oxygen delivery will be severely decreased. After 2-5 minutes, increase to full flow (see NCH ECMO Matrix)
21. Return ventilator to previous settings.
Note:
Immediately after placing the patient on ECMO begin hemofiltering. This will require quickly priming and
installing the correct ultrafilter. As effluent is taken off the circuit, replace this with a balanced combination of
PRBC’s, FFP and Platelets.
22. Change all drips from old circuit to new circuit.
23. Connect new heparin bag, and follow NCH ECMO Heparin infusion, Xa- Administration & Management
protocol.
* Trace heparin infusion to patient to ensure connection
24. Tyband all connections.
25. Document procedure in patient medical record.
55
********NON-EMERGENT********
New Blood Primed Circuit
********NON-EMERGENT********
56
********NON-EMERGENT********
********NON-EMERGENT********
57
********EMERGENT********
Crystalloid Primed Circuit
********EMERGENT********
58
********EMERGENT********
********EMERGENT********
59
Quadrox D/ iD membrane oxygenator set up, prime and changeout
Personnel: ECMO Primer or Perfusionist
Equipment:
Directions and supplies in light blue for Quadrox iD only.
PPE
1- Quadrox D/iD oxygenator
1- 1L sterile 0.9% NaCl
Alcohol Prep pads
Betadine
60mL syringe x 2ea
Blue catheter tip adaptor
1- 3/8” raceway tubing
1- 1/4” raceway tubing
2- 3/8” perfusion adaptor
1- hemofilter 1/4” stub
2- Two-way stopcock
2- Three-way stopcock
3- 6” line
2- disposable Abbott™ transducers
2- hemotap valves
1- 1/8” line (from oxygenator purge line)
2- 2ft. lines
2- sterile blades
2- sterile scissors
5- tybands
8- sterile tubing clamps
2- 3/8” straight connectors
2- 3/8” x 1/4” reducing connectors
1- pack of sterile caps
60
Specifications: Jostra Quadrox D™
De-airing port
Luer port
blood in
blood out
Specifications Maquet Quadrox iD
Quadrox D
Quadrox iD
0.5 – 7 L/min
0.2 – 2.8 L/min
0.1L/min - no maximum
0.1 – 5.6L/min
Prime Volume
250 mL
81mL
Gas Membrane
Diffusion
Polymethylpentene
Diffusion
Polymethylpentene
Surface Coating
Safeline®
Bioline
Flow Range
Gas flow
61
Unique air handling
capabilities
Self venting hydrophobic
port
Self venting hydrophobic
port
1.8 M2
0.8M2
Heat Exchanger
Polyeurethane
Polyeurethane
HX Surface Area
0.6 M2
0.15M2
Surface Area
Outcome:
Safe changeout of oxygenator without complications.
Goal: Insertion of crystalloid primed, fully functioning oxygenator.
Steps: Set up
1.
2.
3.
4.
Verify expiration dates on all supplies.
Check all packages for: tears, holes, water marks, sterilization confirmation. Apply PPE.
Open oxygenator and attach to holder.
Open and hang 1L sterile 0.9% NaCl, spike both ports on NaCl bag with hemotap valves in closed position, attach
3/8” perfusion adaptors to each hemotap valve.
5. Open sterile raceway tubing, clean center of raceway tubing with betadine then alcohol x 2, then cut in center with
sterile blade to create 2 equal length pieces.
6. Attach 3/8” raceway tubing to one of the 3/8” perfusion adapters on the NaCl bag and inlet of the oxygenator. Then
attach 2nd piece raceway tubing to outlet of oxygenator and the other 3/8” perfusion adaptor on NaCl bag in a sterile
fashion.
Attach 3/8” raceway tubing to one of the 3/8” perfusion adapters on the NaCl bag and 3/8” x 1/4” reducer
then to 6” piece of 1/4” tubing, then to inlet of the oxygenator. Then attach 2nd piece of 3/8” raceway tubing
to the other perfusion adaptor on NaCl bag connect free end to 3/8” x 1/4” reducer then to 6” piece of 1/4”
tubing then to outlet of oxygenator in a sterile fashion.
7. Attach 6” lines to the pre- & post-oxygenator transducer ports on the oxygenator. Attach 3-way stopcocks to each 6”
line, then attach 2ft lines to each stopcock and to the transducer.
8. Attach 2” hemofilter stub to 2-way stopcock and then attach to the post-oxygenator 1/4” outlet port.
Attach CDI and hemofilter large bore tubing directly to oxygenator.
9. Attach 1/8” line to 2-way stopcock then attach the 1/8” line to the top luer port on the outlet side of the
oxygenator.
Steps: Prime
1.
2.
3.
4.
5.
Clamp raceway before oxygenator and open outlet on 0.9% NaCl hemotap valve to let tubing fill to clamp.
Remove yellow oxygenator inlet air purge cap, open clamp and fill oxygenator.
Purge air from pre/post oxygenator transducer lines, 1/4” post oxygenator port and top/outlet oxygenator port.
Open other hemotap valve.
Load raceway tubing into roller pump, turn ON power to pump and increase pump flow to 500mL/min. Continue to
de-air all tubing and oxygenator while recirculating
6. Once de-aired, turn OFF pump, remove raceway from rollerhead and proceed to patient bedside.
7. Prep inlet and outlet of oxygenator with alcohol x 2.
8. Double clamp inlet (2ea) and outlet (2ea) of oxygenator with sterile tubing clamps within prepped area and cut
between clamps with sterile blade. Leave clamps on oxygenator sides so not to de-prime oxygenator.
9. Attach 3/8” straight connector to inlet and outlet of oxygenator and maintain sterility.
Steps: Insertion
62
1. Notify attending/ECMO physician.
2. Apply PPE.
3. If not emergent, prep tubing in area to be cut pre and post oxygenator with betadine (leave on tubing for 2 minutes)
then remove betadine with alcohol prep pad x 2.
4. Remove all loose items from scrub top pockets and from around neck to include pens, ID badge, jewelry, etc.
5. Consider placing patient on emergency ventilator settings.
6. Pause the ultrafilter and all fluids going to the ECMO circuit.
7. Turn off water line valves and remove from oxygenator.
8. Turn CDI 500 and ultrafilter shunt 2-way & 3-way stopcocks OFF.
9. Remove these from oxygenator ports and cap sterile.
10. Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is
greater).
11. Remove patient from ECMO (Venous - Bridge - Arterial). Remove sweep gas flow line
from oxygenator.
12. STOP arterial pump.
13. Double clamp with sterile clamp within prepped area of tubing pre and post oxygenator.
14. Cut between tubing clamps with sterile scissors.
15. Remove old oxygenator and cables from pre/post oxygenator transducers, disconnect gas line.
16. Attach inlet tubing with saline squirt to connector on new oxygenator inlet air-free.
17. Remove all clamps associated to inlet of new oxygenator.
18. Attach outlet tubing with saline squirt to connector on new oxygenator outlet air-free.
19. Remove all clamps associated with oxygenator outlet.
20. Attach new transducers to pre/post oxygenator cables.
21. Recirculate pump at 20mL/Kg/minute or 50mL/min (whichever is greater) through bridge until saline is mixed
(approximately 15sec) and total de-airing has been accomplished.
22. While recirculating at 20mL/Kg/minute or 50mL/min (whichever is greater), place patient back on ECMO (Arterial –
Bridge - Venous). Reattach gas line to new oxygenator, resume prior settings, noting that the gas flow may need to
be reduced with new oxygenator.
23. Resume previous blood flow rate as read by the flow probe.
24. Attach water lines to new oxygenator, open line valves and set temperature to previous setting.
25. Return ventilator to previous settings.
26. Attach CDI 500 shunt and ultrafilter shunt back to new oxygenator and open shunts.
27. Resume ultrafiltration and all fluid administration.
28. Tyband all new connections.
29. Draw pre/post oxygenator, patient blood gases and calibrate CDI 500™ within 15 minutes of changeout to assess
new oxygenator function.
30. Zero pre/post oxygenator transducers.
Document:
Time OFF and ON ECMO
Procedure performed
Reason for changeout
Any complications
Patient’s response
63
Trouble shooting:
1. Poor oxygenation/ventilation after oxygenator changeout:
a. Check blender settings for FiO2/sweep gas flow rate.
b. Check to see that gas line is attached to the new oxygenator.
2. Transducer readings erroneous
a. Re-zero pre/post oxygenator transducers
3. Patient cooling:
a. Check that water bath is properly set and waterline valves are turned on.
Better Bladder™ changeout
Personnel: Primer or Perfusionist
Equipment:
Apply PPE
Sterile 1/4” Better Bladder™ (BB14) or 3/8” Better Bladder™ (BBB38)
2- 1/4” straight connector or
2- 3/8” straight connector or
1- 3/8” x 1/2” reducing connector and 1- 3/8” straight connector
1L 0.9% NaCl
Hemotap valve
2- 60mL syringe
1- 2 way stopcock
1- 10mL syringe
6- sterile tubing clamps
1- Sterile scissors
1- pack of sterile caps (included with Better Bladder)
Alcohol prep pads
Betadine
Tybands and gun
Specifications: Sterile 1/4” Better Bladder™ (BB14) 25mL
Sterile 3/8” Better Bladder™ (BBB38) 175mL
Outcome: Bladder changeout without complications
Goal: Replace clotted or ruptured bladder
Steps: Assembly & Prime
1.
2.
3.
4.
Open 1L 0.9% NaCl bag.
Attach closed hemotap valve.
Attach 60mL syringe to hemotap valve and withdraw 60mL volume x 2.
Open sterile Better Bladder™ (1/4” or 3/8”) and attach 2 way stopcock and 10mL syringe to pressure transducer port
64
5.
6.
7.
8.
9.
10.
Apply PPE
Clamp tubing with sterile clamp below Better Bladder™.
Fill Better Bladder™ with 0.9% NaCl syringe until full.
Once fully primed, clamp open end of Better Bladder™ with sterile clamp.
Attach appropriate connector to each end of the Better Bladder™ beyond top and bottom clamps.
Cap ends with sterile caps removed from Better Bladder™.
Steps: Insertion
1. Notify attending/ECMO physician.
2. If not emergent, prep tubing in area to be cut above and below Better Bladder™ with betadine (leave on tubing for 2
minutes) then remove betadine with alcohol prep pad x 2.
3. Remove all loose items from scrub top pockets and from around neck to include pens, ID badge, jewelry, etc.
4. Consider placing patient on emergency ventilator settings.
5. Pause the ultrafilter and all fluids going to the ECMO circuit.
6. Quickly decrease the pump flow to idle (20mL/Kg/minute).
7. Remove patient from ECMO (Venous - Bridge - Arterial). Remove gas line from oxygenator.
8. STOP arterial pump.
9. Double clamp with sterile clamps within prepped area of tubing above and below Better Bladder™.
10. Cut between tubing clamps with sterile scissors.
11. Remove old bladder.
12. Attach venous tubing to connector on new bladder inlet with saline flush air-free.
13. Remove all clamps associated to inlet of new bladder.
14. Attach raceway tubing to connector on new bladder outlet with saline flush air-free.
15. Remove all clamps associated with bladder outlet.
16. Recirculate pump at idle through bridge until saline is mixed (approximately 15sec) and total de-airing has been
accomplished.
17. While recirculating at idle, place patient back on ECMO (Arterial – Bridge - Venous). Reattach gas line to oxygenator.
18. Resume previous flow rate as read by the flow probe.
19. Return ventilator to previous settings.
20. Re-zeroing bladder transducer is appropriate (refer to zeroing tranducer protocol).
21. Add or remove air via syringe from the outer bladder transducer port to visualize pulsing of bladder.
22. Resume ultrafiltration and all fluid administration.
23. Tyband all new connections.
Document:
Time OFF and ON ECMO
Procedure performed
Reason for changeout
Any complications
Patient’s response
65
Raceway prime and changeout
Personnel: ECMO Specialist, Primer or Perfusionist
Equipment:
PPE
Sterile scissors
Sterile St. Gobain® Super Tygon™ raceway tubing 3/8” or 1/2”
2- 3/8” or 2- 1/2” straight connectors
or
2- 1/4” x 3/8” or 2- 3/8” x 1/2” reducing connectors
or
1- 3/8” x 1/2” reducing connector and 1- 1/2” straight connector
1L 0.9% NaCl
Hemotap valve
60mL syringe
2- sterile tubing clamps
1- pack of sterile caps
Alcohol prep pads
Betadine
Outcome: Raceway changeout without complications
Goal: Replace worn or ruptured raceway
Steps: Assembly & Prime
1.
2.
3.
4.
5.
6.
7.
8.
Apply PPE.
Open 1L 0.9% NaCl close and attach a hemotap valve.
Attach 60mL syringe to hemotap valve and withdraw 60mL volume.
Open sterile tubing and clamp one end with sterile tubing clamp.
Fill tubing 60mL at a time with syringe until full.
Once fully primed, clamp open end of raceway.
Open and attach appropriate connector to each end of the raceway.
Cap ends.
Steps: Insertion
1. Notify attending/ECMO physician.
2. If not emergent, prep tubing in area to be cut with betadine (leave on tubing for 2 minutes) then remove betadine
with alcohol prep pad x 2.
3. Remove all loose items from scrub top pockets and from around neck to include pens, ID badge, jewelry, etc.
4. Consider placing patient on emergency ventilator settings.
5. Pause the ultrafilter and all fluids going to the ECMO circuit.
66
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO (Venous - Bridge - Arterial). Remove gas line from oxygenator.
STOP arterial pump and turn OFF power to pump.
Remove old raceway tubing from raceway.
Double clamp with sterile clamps within prepped area of tubing.
Cut between tubing clamps with sterile scissors.
Attach post bladder tubing with saline flush to connector on new raceway inlet tubing air-free
Attach new raceway outlet connector with saline squirt to pre-oxygenator tubing air-free
Remove all tubing clamps around raceway tubing
Insert tubing in rollerhead raceway.
Turn power ON to pump, let pump do internal test, turn flow up-down, then recirculate at 20mL/Kg/minute or
50mL/min (whichever is greater).
Recirculate through bridge until saline is mixed (approximately 15sec) and total de-airing has been accomplished.
While recirculating at 20mL/Kg/minute or 50mL/min (whichever is greater), place patient back on ECMO (Arterial –
Bridge - Venous). Reattach gas line to oxygenator.
Resume previous flow rate as read by the flow probe.
Return ventilator to previous settings.
Resume ultrafiltration and all fluid administration.
Tyband all new connections.
Document:
Time OFF and ON ECMO
Procedure performed
Reason for changeout
Any complications
Patient’s response
Trouble shooting:
See occlusion policy for proper raceway occlusion post changeout.
Heater Changeout
Personnel: ECMO Specialist
Equipment:
Functional Cincinnati Subzero (CSZ) ECMO Heater
3- 1L sterile water
Female-Female Hanson connector
Goal:
Replacement of failing ECMO heater without incident or unnecessary cooling
of the ECMO patient.
Note:
67
This procedure does not affect the function or safety of the ECMO circuit itself. The patient continues with ECMO
support throughout the procedure. Thermo-regulation will be severely compromised and should be dealt with by preheating the replacement CSZ heater prior to changing.
Warning: If the power supply to the CSZ ECMO heater is interrupted, when power is returned, the heater will default to
37° Celsius.
Steps:
1. Turn OFF power to defective heater.
2. Close waterline valves and remove waterlines from heat exchanger.
3. Send personnel to get functional ECMO heater.
4. Remove defective heater from ECMO pump base.
5. Keep patient warm with blankets, Bair Hugger, heat lamps, warm water bottles, etc. If the heater is or will be off for
an extended period.
6. When functional heater arrives, plug into separate emergency outlet. Add sterile water (NEVER add saline, as this
will corrode internal parts of heater). Connect the two water lines via the female-female connector (drawer 6 in the
ECMO prime cart) Check that water line valves are open and turn ON power. Set temperature to previous setting.
7. Once the heater has achieved the proper temperature, turn heater OFF, close water line valves, remove femalefemale connector, place on ECMO pump base and attach waterlines to heat exchanger.
8. Open water line valves, turn heater ON and check flow indicator for proper flow.
9. Discontinue alternative warming measures for the patient.
10. Send defective water heater to biomed department.
Document:
Procedure peformed
Reason for procedure
Any complications
Patient’s response (if any)
Record ECMO control # for new heater on ECMO flowsheet
Roller Pump Changeout
Personnel: ECMO specialist, primer or perfusionist
Equipment:
Functional Jostra® roller pump
Proper tubing guide inserts – 1/4”, 3/8” or 1/2”
Pump calibration set to proper raceway size
RotaFlow™ Emergency drive unit (hand-crank)
Note:
Also refer to the following protocols:
Hand-cranking the Roller Pump
Checking Occlusion – roller pump
68
Goal: Safe changeout of defective pump without complications
Steps:
If pump fails:
1. Turn OFF roller pump power switch (front of cart base P2).
2. Turn ON roller pump power switch and wait for internal check to complete turn flow up-down.
3. If roller pump resets, resume pump flow as ordered.
4. If the above does not work, turn OFF roller pump power switch (front of cart base P2). Remove all loose items from
scrub top pockets and from around neck to include pens, ID badge, jewelry, etc. Remove pump cover and insert
hand crank (located front console base drawer). Refer to “Hand cranking roller pump” protocol.
5. Notify physician, primer and/or perfusionist.
6. Slowly begin cranking counter-clockwise at the same RPM’s the pump was previously running at (flow direction is
bladder to membrane).
7. Monitor venous return via bladder transducer pressure, this should remain the same as it was while the pump was
working.
8. RPM should have been recorded in ECMO flowsheet to remind personnel where pump was previously running. The
Transonic™ flowprobe should be reading the flow being delivered to patient.
9. Observe pre-membrane pressure, SvO2, RPM’s & arterial pressure for adequacy of flow.
10. Send personnel to get replacement roller pump.
UPON PUMP ARRIVAL
11. Pause the ultrafilter/replacement fluid.
12. Consider emergency ventilator settings.
13. Stop hand cranking.
14. Remove patient from ECMO (Venous - Bridge - Arterial).
15. Remove sweep gas flow line from oxygenator.
16. Remove raceway from pump.
17. Remove current roller pump and replace with backup roller pump on cart base.
18. Reload raceway tubing (check for proper direction).
19. Power ON new roller pump (front of cart base P2), let pump do internal test, turn flow up-down.
20. Check tubing size indicator on pump menu display.
21. Check occlusion according to NCH ECMO protocol Occlusion.
22. Recirculate briefly through bridge. While recirculating at 20mL/Kg/minute or 50mL/min (whichever is greater), place
patient back on ECMO (Arterial – Bridge - Venous). Reattach sweep gas flow line to oxygenator.
23. Resume previous flow rate as read by the flow probe.
24. Return ventilator to previous settings.
25. Resume ultrafiltration/replacement fluid administration.
26. Send defective pump to biomed.
Document:
Time off and on ECMO
Procedure performed
Reason for changeout
69
Any complications
Patient’s response
Jostra RotaFlow™ Centrifugal Pump Changeout
Personnel: ECMO specialist, primer or perfusionist
Equipment:
Functional Jostra RotaFlow™ centrifugal pump console
Pump set in ‘ART’ mode
Standard hospital grade power cord
RotaFlow™ Emergency drive unit (hand-crank)
Note:
Also refer to the following protocols:
Hand-cranking RotaFlow™
Goal: Safe changeout of defective pump without complications
Steps:
If pump fails:
1. Turn OFF RotaFlow™ pump power switch (front panel of pump).
2. Turn ON RotaFlow™ pump power switch and wait for internal check to complete.
3. After initial power up process, press and hold ‘clamp’ button for 3 seconds, then press and hold ‘level’ button for
three seconds.
4. If pump resets, resume pump flow as ordered.
5. If the above does not work, turn OFF pump power switch (picture at right). Remove all loose items from scrub top
pockets and from around neck to include pens, ID badge, jewelry, etc. Clamp arterial line between the disposable
centrifugal pump and oxygenator. Remove disposable centrifugal pump from drive unit and insert into RotaFlow™
Emergency drive unit (hand-crank). Refer to “Hand cranking RotaFlow™” protocol.
6. Notify physician, primer and/or perfusionist.
7. Remove tubing clamp and slowly begin hand-cranking.
8. Slowly begin cranking at the same RPM’s the pump was previously running.
9. Monitor venous return via bladder transducer pressure, this should remain the same as it was while the pump was
working.
10. RPM should have been recorded in ECMO flowsheet to remind personnel where pump was previously running. The
Transonic™ flowprobe should be reading the flow being delivered to patient.
11. Observe pre-membrane pressure, SvO2, RPM’s & arterial pressure for adequacy of flow.
12. Send personnel to get replacement Jostra RotaFlow™ centrifugal pump console.
UPON PUMP ARRIVAL
13. Pause the ultrafilter/replacement fluid.
14. Consider emergency ventilator settings.
15. Stop hand cranking.
16. Remove patient from ECMO (Venous - Bridge - Arterial).
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17. Remove sweep gas flow line.
18. Remove current centrifugal pump console and replace with backup centrifugal pump console on cart base.
19. If in “STAND ALONE” mode, a medical grade power cord will need to be plugged into the back of pump console (See
insert), and into wall emergency (red) plug.
20. Power ON to new centrifugal pump console, let pump do internal test. After initial power up process, press and hold
‘clamp’ button for 3 seconds. Press and hold ‘level’ button for 3 seconds.
a. Check that pump console is in the “ART” mode.
21. Remove disposable centrifugal pump from RotaFlow™ Emergency drive unit (hand-crank) and return to drive unit.
22. Recirculate briefly through bridge. While recirculating at 20mL/Kg/minute or 50mL/min (whichever is greater), place
patient back on ECMO (Arterial – Bridge - Venous). Reattach sweep gas flow line to oxygenator.
23. Resume previous flow rate as read by the flow probe.
24. Return ventilator to previous settings.
25. Resume ultrafiltration/replacement fluid administration.
26. Send defective pump to biomed.
Document:
Time OFF and ON ECMO
Procedure performed
Reason for changeout
Any complications
Patient’s response
Power Cord
Stopcock Changeout
Personnel: ECMO specialist, primer or perfusionist
Equipment:
PPE
Tubing clamp
2 way or 3-way stopcock
Occlusive caps (1-2)
Alcohol pads x 4
3mL luered ECMO flush syringe
Note: There is no need to remove patient from ECMO for this procedure.
Steps:
1. Apply PPE.
2. Clamp pigtail.
3. Vigorously wipe stopcock/pigtail interface with alcohol for 15 seconds, wipe stopcock/pigtail interface with second
alcohol pad and allow to dry for 30 seconds. Remove old stopcock and discard in biohazard container.
4. Wipe open pigtail port with alcohol.
5. Attach 3mL ECMO flush syringe to stopcock. Flush & de-air. Close stopcock.
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6. Firmly attach flushed stopcock to pigtail.
7. Remove tubing clamp, open stopcock and draw back 1mL to remove any air. Keep control of plunger on syringe,
especially if in a high pressure area of circuit.
8. Remove waste syringe, wipe port with alcohol and allow to dry for 30 seconds, attach new 3mL ECMO flush syringe
and flush pigtail until clear.
9. Turn stopcock off to circuit.
10. Place occlusive caps on open stopcock port if present.
Document:
Date and time
Location of stopcock changeout
Pigtail Changeout
Personnel: ECMO specialist, primer or perfusionist
Equipment:
PPE
6” Pigtail
2-way or 3-way stopcock
ECMO flush (0.45% NaCl with 1unit heparin/mL)
2- tubing clamps
Occlusive caps (1-2)
Alcohol prep pads x 3
Note: Only 15-20 seconds should be required for this procedure.
Goal: Remove/Reinstitute patient from/onto ECMO safely with placement of new pigtail.
Steps:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Apply PPE.
Connect the new stopcock & pigtail to each other and prime with ECMO flush. Leave the flush syringe attached.
Notify attending/ECMO physician.
Consider placing patient on emergency ventilator settings.
Pause the ultrafilter and all fluids going to the ECMO circuit.
Vigorously wipe pigtail luer/circuit interface with alcohol for 15 seconds, wipe again with second alcohol pad and
allow to dry for 30 seconds.
Quickly decrease the pump flow to idle (20mL/Kg/minute).
Remove patient from ECMO (Venous - Bridge - Arterial). Remove gas line from oxygenator.
STOP arterial pump.
Clamp around luered connector where pigtail is to be changed.
Remove the old pigtail.
Wipe open pigtail port with alcohol.
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13.
14.
15.
16.
17.
18.
Using the flush syringe on the new pigtail, drip fluid into the luer and connect new pigtail.
Remove clamps and draw back slightly to de-air.
Turn stopcock OFF to the circuit.
Attach 3mL ECMO flush syringe to stopcock. Flush & de-air. Close stopcock.
Recirculate at idle through bridge (approximately 15sec).
While recirculating at idle, place patient back on ECMO (Arterial – Bridge - Venous). Reattach gas line to new
oxygenator.
19. Resume previous flow rate as read by the flow probe.
20. Return ventilator to previous settings.
21. Resume ultrafiltration and all fluid administration.
Document:
Time off and on ECMO
Procedure done
Reason for changeout
Any complications
Patient’s response
Zeroing Pressure Transducers
Personnel: ECMO Specialist
Equipment:
None
Outcome: Properly zeroed pressure transducer
Note: The pressure transducer zero should be checked
before the initiation of ECMO and then once a
shift at a minimum.
Steps:
1. Override the transducer to be zeroed.
Press #1 safety button and pressure override
button
simultaneously to override the
transducer.
2. Remove the cap from the appropriate transducer.
3. Turn the transducer off to the circuit.
4. Zero the transducer.
Press#1 safety button and “0” simultaneously and release.
The “0” soft key will illuminate (green)
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The corresponding pressure display should read 0 mmHg.
5. Open the transducer to the circuit.
6. Re-cap the transducer.
7. Take pressure transducer off override.
Press the corresponding override soft key to disable override.
Normal servo regulation limits
Transducer
High
Limit
Low
Limit
PreOxygenator
350
-1
PostOxygenator
300
-1
Bladder
100
-20
Hand-cranking the Jostra® roller pump
Personnel: ECMO specialist, primer or perfusionist
Equipment:
Hand-crank
Uninterrupted power supply (UPS) unit
Roller pump
Note:
Hand cranking is intended for use in emergency situations only (mechanical pump failure, electrical failure or
wall/internal battery power failure).
Hand cranking should never be performed when the pump has stopped due to: a pressure violation or bubble alarm.
Hand cranking in either of the above situations may have significant catastrophic consequences. It is imperative that
the ECMO specialist , primer or perfusionist examine these alarms immediately and determine a resolution other than
hand cranking.
Goal:
To provide adequate cardiac output and oxygen delivery to the patient during mechanical pump failure, electrical failure
or wall/internal battery power failure.
Steps: Pump has a mechanical failure, electrical failure or wall/battery power failure:
1. Turn OFF roller pump power switch (front of cart base P2). Remove all loose items from scrub top pockets and
from around neck to include pens, ID badge, jewelry, etc. Remove pump cover and insert hand crank (located
front console base drawer).
2. Notify physician, primer and/or perfusionist. Ask that the uninterrupted power supply (UPS) unit be brought to
the bedside.
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3. Slowly begin cranking counter-clockwise (follow the arrows) at the same RPM’s
the pump was previously running (flow direction is bladder to membrane).
Note: Below methods describe dealing with a wall failure followed by an internal
battery power type failure! A failure dealing with mechanics of the roller pump or
electrical system of the roller pump (exclusively) will require a roller pump changeout.
Follow steps in ECMO protocol “Roller Pump Changeout”
4. RPM should have been recorded in ECMO flowsheet to remind personnel where
pump was previously running.
5. Observe patient arterial line pressure for adequacy of flow, if available.
6. Observe bladder pulsatility/volume while hand-cranking.
7. Assemble personnel to continue hand-cranking process. Change to backup personnel as fatigue occurs.
8. Continue until UPS unit can be retrieved from ECMO room.
9. Once UPS unit is at bedside, power ON the UPS, plug ECMO pump base cart power cord into UPS.
10. The UPS unit has a manufacturer guarantee of 3 seconds of back-up power.
Internal testing has resulted in actual battery life of + 30 minutes under a light load with the current UPS.
11. Once the back-up power supply is exhausted, resume handcranking until wall/battery power is restored.
Document:
Time OFF and ON ECMO
Time START and STOP hand cranking
Procedure done
Reason for hand cranking
Any complications
Patient’s response
75
Jostra Base Cart Internal Battery
Hand-cranking the Jostra® RotaFlow centrifugal pump
Personnel: ECMO specialist, primer or perfusionist
Equipment:
RotaFlow™ Emergency drive unit (hand-crank)
Back-up power supply unit (internal)
With new, fully charged batteries, the unit (under normal load and flowing at 5L/min) has a potential to run for
1.5 hours.
Uninterrupted power supply (UPS) unit
Standard medical grade power cord
Note: Hand-cranking is intended for use in emergency situations only (mechanical pump failure, electrical failure or
wall/internal battery power failure).
Hand cranking should never be performed when the pump has stopped due
to: a pressure violation or bubble alarm. Hand cranking in either of the
above situations may have significant catastrophic consequences. It is
imperative that the ECMO specialist , primer or perfusionist examine these
alarms immediately and determine a resolution other than hand cranking.
Note: Below methods describe dealing with a wall failure followed by an
internal back-up battery power type failure. A failure dealing with mechanics
of the RotaFlow centrifugal pump or electrical system of the RotaFlow
centrifugal pump (exclusively) will require a RotaFlow centrifugal pump
changeout. Follow steps in ECMO protocol “RotaFlow Centrifugal Pump
Changeout”
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Goal:
To provide adequate cardiac output and oxygen delivery to the patient during mechanical pump failure, electrical failure
or wall/internal battery power failure.
Steps:
If mechanical pump failure, electrical failure or wall/ internal pump back-up power supply failure:
1. Turn OFF RotaFlow™ pump power switch (front of console). Remove all loose items from scrub top pockets and
from around neck to include pens, ID badge, jewelry, etc. Remove disposable pump from drive unit and insert
into RotaFlow™ Emergency drive unit
(located on cart pole and mounted).
2. Notify physician, primer and/or
perfusionist, call for UPS unit.
3. Slowly begin cranking at the same
RPM’s the pump was previously
running. The emergency drive unit
is only able to be turned in onedirection to achieve blood flow. The
read out on the emergency drive
unit is in RPM’s only.
4. Observe bladder pulsatility/volume
status while hand cranking.
5. RPM should have been recorded in ECMO flowsheet to remind personnel where pump was previously running.
6. Observe patient arterial line pressure for adequacy of flow.
7. Assemble personnel to continue hand-cranking process. Change to backup personnel as fatigue occurs.
8. Continue until UPS unit can be retrieved from ECMO room.
9. Once UPS unit is at bedside, power ON the UPS, plug ECMO pump base cart power cord into UPS unit or if in
STAND ALONE mode, plug standard medical grade power cord into back of RotaFlow™ console (#6 on diagram
2.1.3 Rear View) and other end into the UPS unit.
10. Place disposable centrifugal pump back into drive unit, turn on RotaFlow™ pump power switch (front of
console), override ‘valve’ and ‘level’ alarm and resume flow per physician order.
11. The back-up power supply unit has a manufacturer guarantee of 3 seconds of back-up power.
Internal testing has resulted in actual battery life of + 30 minutes under a light load with the current UPS.
12. Once both back-up power supplies are exhausted, resume hand-cranking until wall/battery power is restored.
Document:
Time OFF and ON ECMO
Time START and STOP hand cranking
Procedure performed
Reason for hand cranking
Any complications
Patient’s response
77
Jostra Base Cart Internal Battery
Occlusion- Setting the Occlusion on the Roller Pump
Personnel: ECMO Primer, Perfusionist
Equipment:
3 - Clamps
Watch with second hand
Outcome: Properly adjusted roller pump occlusion which will maintain forward fluid flow at very low revolutions per
minute (RPM’s), while not causing excessive tubing degradation or blood hemolysis within the roller head.
Goal: 35 gtts in 15 seconds
Note: The occlusion should be set prior to placing a patient on ECMO support.
It may be necessary to set/verify the occlusion while a patient is on ECMO.
78
Steps: NEW SETUP
1.
2.
3.
4.
5.
Crystalloid primed circuit from the reservoir to the oxygenator (entire venous side).
Clamp just prior to oxygenator, distal to pre-oxygenator port.
Load raceway (boot) into the roller pump, position so that only one roller is in contact with raceway tubing.
Open pre-oxygenator port and count gtts.
Loosen/tighten the occlusion by depressing the occlusion lock (2) and turning the occlusion adjustment knob (1) in
one click intervals until desired 35 gtts/15 seconds is achieved.
Ensure occlusion lock (2) is in the locked (a) position when finished.
6. Record occlusion on Jostra prime sheet.
7. Remove clamp and continue priming the circuit.
Steps: PATIENT on ECMO
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Inform attending/ECMO physician.
Consider placing patient on emergency ventilator settings.
Remove all loose items from scrub top pockets and from around neck to include pens, ID badge, jewelry, etc.
Attach a 60mL syringe filled with NaCL or ECMO flush to pigtail on the venous side of circuit pre-roller head.
Pause the ultrafilter and all fluids going to the ECMO circuit.
Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO (Venous - Bridge - Arterial).
STOP arterial pump.
Close all shunts within the ECMO circuit.
Place a clamp just prior to oxygenator, distal to pre-oxygenator port.
Pressurize the venous side of the circuit to ~ 60mmHg (read on the bladder pressure transducer) with the 60mL
syringe (from step #4 above).
12. Open pre-oxygenator port and count gtts.
79
13. Open roller head cover.
14. Loosen/tighten the occlusion by depressing the occlusion lock (2) and turning the occlusion adjustment knob (1) in
one click intervals until desired 35 gtts/15 seconds is achieved.
15.
16.
17.
18.
19.
20.
21.
22.
Ensure occlusion lock (2) is in the locked (a) position when finished.
Close roller head cover.
Remove pre-oxygenator clamp, open bridge and begin recirculating.
While recirculating at 20mL/Kg/minute or 50mL/min (whichever is greater), place patient back on ECMO (Arterial –
Bridge - Venous).
Resume previous flow rate as read by the flow probe.
Return ventilator to previous settings.
Resume ultrafiltration and all fluid administration.
Preoxygenator port must be flushed with ECMO heparin flush and re-zeroed at this time.
Document procedure in patient medical record.
Raceway walking
Personnel: ECMO Primer or Perfusionist
Equipment:
White tape
Note: Any raceway size tubing should be rotated by 1,000,000 impacts to the tubing. This is calculated by multiplying:
RPMs (average throughout run) x 2 (impacts/RPM) x 60 (mins/hour) x # of hours on ECMO = impacts
ie. 40 x 2 x 60 x 96 = 460,800 impacts
Outcome: Raceway walk without complications
Goal: Rotate worn tubing from raceway to pre-pump side
Steps:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Notify attending/ECMO physician.
Remove all loose items from scrub top pockets and from around neck to include pens, ID badge, jewelry, etc.
Mark tubing at pump outlet with small piece of white tape.
Consider placing patient on emergency ventilator settings.
Pause the ultrafilter and all fluids going to the ECMO circuit.
Quickly decrease the pump flow to 20mL/Kg/minute or 50mL/min (whichever is greater).
Remove patient from ECMO (Venous - Bridge - Arterial). It is not necessary to remove the sweep gas since the
procedure typically takes less than 30 seconds.
STOP arterial pump and turn OFF power to pump.
Remove old raceway tubing from raceway.
Shift tubing so that the piece of marking tape is positioned at pump inlet.
Reload raceway with tubing. There should be an unworn section of tubing placed into the raceway.
Confirm that tubing is loaded in the proper direction.
Replace cover and close.
Turn pump ON and recirculate briefly at 20mL/Kg/minute or 50mL/min (whichever is greater).
Return patient to ECMO support by (Arterial – Bridge - Venous).
80
Document:
Time OFF and ON ECMO
Procedure performed
Reason for walking raceway (maintenance, excessive wear, splitting, etc.)
Any complications
Patient’s response
Trouble shooting:
See occlusion policy for proper raceway occlusion post walking.
Air-Free Connection or Fluid Filled Connection
Personnel: ECMO Specialist
Equipment:
Clean Gloves
Goggles
3mL filled ECMO flush syringe
Outcome: Connection of a fluid filled line, tubing or syringe to an ECMO circuit pigtail or stopcock in which the final
outcome is a fluid-to-fluid joint void of any air.
Goals: All connections to the ECMO circuit should be performed with the following goals in mind: 1) Asepsis 2) Air
free 3) Minimal/no fluid loss.
Steps:
1. Prime tubing/line or syringe to be attached to the ECMO circuit so that it is free of any air and fluid filled to the
end of the tubing or syringe.
2. Vigorously wipe stopcock/syringe interface with alcohol for 15 seconds, wipe stopcock/syringe interface with
second alcohol pad and allow to dry for 30 seconds. Open stopcock & use 3mL luered syringe (in place prior to
beginning process) to remove 1mL of waste from the circuit. Close stopcock.
3. Discard waste syringe into biohazard container.
4. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
5. Place the ECMO flush syringe into the end of the stopcock slowly fill the stopcock as the syringe is withdrawn.
6. Connect the tubing/line or syringe to the stopcock.
7. Verify air-free connection.
8. If air remains within the stopcock connection, disconnect and repeat steps 5-6 above.
9. Once the connection is air-free, open the stopcock and begin infusion.
81
Air Removal
Personnel: ECMO Specialist
Equipment:
Personnel Protective Equipment (PPE)
2- Tubing Clamps
10mL or larger syringe
Outcome:
Removal of air embolus from within the ECMO circuit.
Goal: Determination of air entrainment origin.
Location of air in order of increasing severity:
1.
2.
3.
4.
5.
6.
Venous Line/Better Bladder
Inlet/Outlet of the roller head
Inlet of Disposable Centrifugal pump
Inlet side of the oxygenator
Arterial Line Filter
Arterial Line
Causes of circuit air in order of likelihood:
1.
2.
3.
4.
5.
6.
7.
Air from fluid/blood product administration
Inadvertent air entry via right atrial/central catheter
Venous cannula side hole exposure
Loose or broken stopcock or pigtail
Excessive negative pressure
Broncho-capillary communication
Pressurized gas phase
Note: The bubble detector is set to STOP the ECMO pump if it detects air!
The bubble detector on the ECMO system will detect bubbles as small as 300µm. In a moving stream of blood, bubbles
of this size may be within the fluid column and impossible to see. If the bubble detector alarms, check the circuit
thoroughly from the bubble detector to the arterial cannula before resuming ECMO support. Bubbles may be incredibly
small (pin point size), but may pose a terminal threat to the patient.
Note: DO NOT HAND CRANK PUMP IF AIR IS ON ARTERIAL SIDE OF CIRCUIT !
Air Location:
Venous Line
Better Bladder
Inlet of roller head/Inlet of disposable centrifugal pump
Arterial Line Filter
Steps:
82
1.
2.
3.
4.
5.
Air in these locations will NOT STOP pump.
Observe air for 60 seconds to determine if it is accumulating.
If accumulating, begin looking upstream for the source of air entry.
Apply PPE
Resolve air entry source if possible. If not possible to resolve and air accumulation is ongoing, immediately notify
the ECMO physician and the primer/perfusionist.
6. Begin removing air by connecting a syringe to the pigtail just prior to the Better Bladder transducer port.
Caution, removing large amounts of blood in an attempt to remove the air may interrupt ECMO support due
to a low bladder pressure.
7. Depending on the blood flow rate, air may not naturally rise to this port and a momentary decrease in pump
flow may be necessary.
8. If decreasing the pump flow does not allow air to be aspirated from the circuit, it may be necessary to
completely remove the patient from ECMO (VBA per protocol) for a brief period of time (seconds). This will
allow the air to rise to the highest point, therefore, it is imperative the port being accessed is the closest port to
the air, and is also the highest port relative to the air’s location.
** If the patient has been removed from ECMO (VBA) you must connect fluid (i.e. 60mL syringe with NaCL) to the
circuit prior to pulling air out of the circuit. Failure to perform this step will lead to additional air entrainment into
the circuit via the gas phase of the oxygenator.**
Before removing a patient from ECMO for air in any of the above locations, notify the ECMO physician and the
primer/perfusionist.
Air Location:
Outlet of the roller head
Inlet side of the oxygenator
Steps:
1.
2.
3.
4.
Observe air for 60 seconds to determine if it is accumulating.
If accumulating, begin looking upstream for the source of air entry.
Apply PPE
Resolve air entry source if possible. If not possible to resolve and air accumulation is ongoing, immediately notify
the ECMO physician and the primer/perfusionist.
5. Remove yellow air purge cap on the inlet side of the Quadrox D®.
6. Allow air to purge from this port.
7. Replace yellow purge cap once air is gone.
DO NOT ATTACH A SYRINGE AND ASPIRATE FROM THIS PORT!
Air Location:
Arterial Line (post arterial line filter)
*** Pump STOPPED by air bubble detection system***
Steps:
1.
2.
3.
4.
Immediately clamp the arterial line above the air or bridge, whichever is proximal to the patient.
Call ECMO physician and primer/perfusionist.
Consider placing patient on emergency ventilator settings.
Clamp venous line above the bridge and open bridge.
83
5. Override bubble detector and begin recirculating through bridge.
6. Remove sweep gas flow from oxygenator.
7. Walk air down arterial line and through bridge into venous side of circuit.
** If the patient has been removed from ECMO (VBA) you must connect fluid (i.e. 60mL syringe with NaCL) to the
circuit prior to pulling air out of the circuit. Failure to perform this step will lead to additional air entrainment into
the circuit via the gas phase of the oxygenator.**
8. Remove venous air as described above.
9. Inspect arterial side of circuit for additional air and remove.
10. Resolve air entry source if possible. If not possible to resolve and air accumulation is ongoing, inform the ECMO
physician and the primer/perfusionist of this condition. If resolved, continue to step #10.
11. Reset bubble detector.
12. While recirculating at idle, place patient back on ECMO (Arterial – Bridge - Venous).
13. Resume previous flow rate as read by the flow probe.
14. Return ventilator to previous settings.
15. Return sweep gas flow line to oxygenator.
16. Document event in patient medical record.
Fluid Infusion
Personnel: ECMO Specialist
Equipment:
Personnel protective equipment (PPE)
Fluid/medication to be administered
84
IV Pump and tubing or syringe pump, syringe and associated tubing.
3mL filled ECMO flush syringe
Outcome: Connection of a fluid or intravenous medication and subsequent syringe pump or IV pump to a pigtail or
stopcock within the ECMO circuit.
Note: Whenever possible all medication should be administered to the patient via a central venous line.
All connections to the ECMO circuit should be performed with the following goals in mind: 1) Asepsis 2) Air
free 3) Minimal/no blood loss.
Before administering any fluid/medication to the ECMO circuit, check the NCH drug card database to assure
compatibility.
Additional Reference:
NCH Drug Card Database (Online)
NCH ECMO protocol Medication Administration
NCH ECMO protocol Air-Free Connection or Fluid filled connection
Steps:
1. Verify: patient name, patient allergies, medication, dose, route, physician order and expiration of syringe.
2. Apply PPE.
3. Prime IV tubing or syringe tubing to be attached to the ECMO circuit so that it is free of any air and fluid filled to
the end of the tubing.
4. Load IV tubing into IV pump and clamp line or load syringe into syringe pump.
5. Input all possible information into IV/syringe pump to include:
Pt. weight
Drug concentration
Infusion concentration per volume
6.
7.
8.
9.
10.
11.
12.
13.
14.
Desired rate or desired volume per time
Vigorously wipe stopcock/syringe interface with alcohol for 15 seconds, wipe stopcock/syringe interface with
second alcohol pad and allow to dry for 30 seconds. Open stopcock & use 3mL luered syringe (in place prior to
beginning process) to remove 1mL of waste from the circuit. Close stopcock.
Discard waste syringe into biohazard container.
Place the ECMO flush syringe into the end of the stopcock slowly fill the stopcock as the syringe is withdrawn.
Connect tubing to port/stopcock in such a manner as to avoid air within the connection.
Verify air-free connection.
If air remains within the stopcock connection, disconnect and repeat steps 8-10 above.
Once the connection is air-free, open the stopcock, unclamp tubing and begin infusion.
Monitor patient for any signs of reaction/sensitivity.
Document administration in patient medical record.
85
Transport of Patient on ECMO
Personnel: ECMO Physician, perfusionist or primer, ECMO Specialist, bedside RN plus 1-2 additional RNs or RRTs.
Equipment:
Full oxygen tank (E-cylinder)
Transport monitor
Volume:
o 250mL 5% albumin or 0.9% NaCl for neonate
o 1L 0.9% NaCl and 500mL 5% albumin for pediatric or adult patient
Emergency medication and intubation boxes
Hemochron™ Signature Elite ACT machine with ACT+ cartridges
Connectors: ¼”× ¼” or ⅜” × ⅜”
1- Sterile scissors
2 extra tubing clamps
Goal: Safe transport to/from location without complications
Note: The Cincinnati Sub-Zero (CSZ) heater will not function during transport.
Steps:
1. Call primer or perfusionist on-call to alert them of urgent transport.
2. If elevator is needed, check for function and accessibility.
3. Prepare all IV pumps for transport.
4. Lower bed and IV poles enough to pass through doorways.
5. Confirm that ECMO internal battery is fully charged.
6. Check for presence of hand cranks.
7. Ensure that no ECMO circuit tubing will kink or become entangled in the wheels.
8. Make arrangements for ventilator to be transported to destination.
9. Assign two RNs to move the bed, one ECMO team member to secure and hold the cannulae, and two ECMO team
members to move the ECMO pump. The primer or perfusionist will coordinate the move.
10. The two ECMO team members moving the pump should position themselves as the “bridge” between the bed and
the pump holding onto both.
11. Patient bed should go first.
12. A clear path should be available from the ICU bedside to the elevator.
13. When ready to transport, detach ventilator and hand ventilate. Disconnect oxygenator sweep gas flow line at
blender and immediately plug into O2 portable tank. Verify E-cylinder sweep gas flow, which should be set as close
to blender settings as possible. Unplug air/O2 lines from wall, roll up and place on ECMO pump cart.
14. Unplug bed, ECMO pump and secure cords. Verify that pump converted to internal battery power correctly and that
there is sufficient charge.
15. During transport everyone should be prepared to react quickly to “stop” commands.
16. When at destination, plug the ECMO pump into wall outlet (preferably red emergency outlet). Verify that pump
internal battery is recharging.
86
17. Reattach air/O2 lines into wall. Switch oxygenator sweep gas flow line from E-cylinder O2 back to blender. Verify
sweep gas flow and FiO2.
18. Resume mechanical ventilation, if possible. Assess patient.
19. Check E-cylinder for adequate PSI (>1500) and change if necessary.
20. If/When transporting back to ICU, refer to line #2 above and follow steps.
Document:
DEPARTURE and ARRIVAL times
Transport location and reason
Any complications
Patient response
Ultrafiltration- Terumo HC05S™ setup and management
Personnel: ECMO Specialist, Primer or Perfusionist
Equipment:
Terumo HC05S
CDI tubing pack
Ultrafiltrate effluent line 1/4”
3- 1/4” female sterile stub
1 liter Normosol
Hemotap valve
2- 2-way stopcocks
1- 3000mL suction cannister
Outcome: Maintenance of patient fluid balance as either equal or negative
Goals: Remove excess fluid from third space and remove excess volume from medications and/or blood products
Specifications: 35 mL prime volume
100 – 500mL/ minute blood flow rate
50mL/minute minimum recommended blood flow rate
Maximum transmembrane pressure 500mmHg
Steps to set up, prime and insert:
1. Connect 1/4” female stubs to inlet and outlet of hemofilter.
2. Connect CDI lines to inlet and outlet of hemofilter via 1/4” stub female ports, connect stopcocks to each end.
3. Add 1/2” stub (from HCO5S package) to effluent port then to that connect a 1/4” ultrafiltrate effluent line with
Roberts clamp closed.
4. Add hemotap valve (closed position) to inlet pressure line of hemofilter and spike 1L Normosol.
5. Allow 300mls (minimum) to flow through blood phase of hemofilter while de-airing.
87
6. Clamp outlet pressure line and open Roberts clamp to allow a minimum of 200mls of fluid to prime the external
chamber of hemofilter and de-air to the end of effluent line.
7. Once internal and external sides are de-aired, cap ends for sterility
8. Next, insert inlet pressure tubing, using ECMO flush in an air-free manner, to the post-oxygenator top port.
9. Then insert the hemofilter outlet pressure tubing, using ECMO flush in an air-free manner, to a venous line port
above bladder.
10. Open all stopcocks to allow blood flow through the hemofilter.
11. Increase pump flow so flow probe reads the ordered flowrate.
12. Finally, attach an IV set pre-primed with 0.9% NaCl to the effluent line and insert into a medication infusion pump.
Connect free end to 3000mL suction canister. Set the medication infusion pump to the desired amount to be
removed per hour as prescribed by the attending physician.
Trouble shooting:
1. If unable to remove fluid via the hemofilter, observe the blood path and look for settling out of red cells. This means
no blood flow is present through the hemofilter. If condition is present, hemofilter changeout is warranted.
2. If the flowprobe and blood pump readings are closer to each other, this may indicate a reduction in circuit shunt
through the hemofilter and may be indicative of clotting. If you are able to remove the prescribed fluid, continue its
use. If not able to remove fluid, then changeout is warranted.
If the pump is continuously stopping/starting because of low venous bladder pressures while hemofiltering, the patient
may be low on preload. The ultrafiltration may need to be stopped for a period of time to allow intravascular volume
stabilization.
88
Hemorrhage Protocol
NICU/PICU Hemorrhage Protocol
Personnel: ECMO Specialist, ECMO attending physician
Outcome: Attainment of hemostasis.
Note: Bleeding greater than 5mL/kg/hr will trigger the Level I portion of this protocol. If the bleeding increases to
greater than 10mL/Kg/hr the bedside specialist should than follow the Level II portion of this protocol. Maintenance of
the below parameters may require running multiple blood components into the ECMO circuit concurrently. To
accomplish this, the ECMO specialist will connect the products to more than one pigtail within the circuit. It will also
require the ECMO specialist to be proactive and order blood components before the respective laboratory value is
outside the set parameters. Ordering of blood products will be based on the laboratory trends not the absolute value.
LEVEL I (5-10ml/kg/hr)
Management
Heparin
TEG
Plt Count
PT
PTT
Hct
Fibrinogen
ACT
Mean Arterial Pressure
rFVIIa
Xa
Frequency
-PRN
Q 6-8 hours
Q 6-8 hours
Q 6-8 hours
Q 6-8 hours
Q 6-8hours
Q hour
Continuously
None
BID
Range
10 - 60units/Kg/Hr
-> 100,000K/mm3
≤ 15 seconds
50-70 seconds
> 35%
> 150mg/dL
170-190 Seconds
Normal for age
-0.3 - 0.6 units/mL
Bleeding 5-10mL/Kg/hr:
Heparin - Heparin should remain at the current rate.
Thromboelastograph (TEG) - A TEG should be considered daily throughout the bleeding period. TEG results are
available ~45minutes after the sample is drawn and therefore treatment of the TEG results will lead to treatment
of historical values. The TEG laboratory test is performed by the Cardiovascular Perfusion Department.
Platelet Count - Platelet counts should be assessed every eight hours. The platelet goal is 100,000/mm3. Platelets
should be administered in quantities of 10mL/Kg in the neonatal and pediatric ECMO patients between (2-20Kg).
Patients > 20Kg will often require 1 or more units of platelets for adequate restoration of their functional platelet
counts. Recheck platelet count 15 minutes post administration.
89
Prothrombin Time (PT) - Assessed every eight hours. The PT should remain ≤ 15 seconds. If greater than 15
seconds, treat with additional fresh frozen plasma (20mL/Kg for patients < 10Kg or 1 or more units for patients >
10Kg).
Partial Thromboplastin Time (PTT) - The normal ECMO patients PTT may be prolonged, dependent upon the
amount and timing of heparin administration. The PTT may start out prolonged and decrease over the hours to
days. The PTT should be checked every six to eight hours. If the PTT is prolonged, consider decreasing the heparin
rate. If a heparin rate change or heparin bolus has been given, wait a minimum of three hours before checking
the PTT.
Hematocrit (Hct) - The CDI 500™ will be utilized to trend the patient’s Hct. It is therefore essential to calibrate the
CDI 500™ with any Hgb/Hct sample. The Hct goal will be >35%.
Fibrinogen - Assessed every six to eight hours. The fibrinogen should be maintained above 150mg/dL. If less than
150mg/dL, treat with one unit of cryoprecipitate. If less than 100mg/dL, treat with two units of cryoprecipitate.
Activated Clotting Time (ACT) - The ACT should be monitored every hour. The range should be 170 - 190 seconds
unless otherwise ordered by the physician.
rFVIIa - Factor VII should not be administered to the ECMO circuit for this level bleeding.
Unfractionated Anti-Xa - The Xa level is generally only checked BID. For the patient bleeding greater than
5mL/Kg/hr, arrangements should be made with the coagulation section of the laboratory to have the Xa level run
BID during weekends and Holidays. The goal for the Xa will be 0.3 - 0.6units/mL. Adjustments should be made
based on the Xa chart located within the Heparin management protocol. If a heparin rate change or bolus has
been given, wait a minimum of three hours before checking the Xa level.
LEVEL II (>10ml/kg/hr)
Management
Heparin
TEG
Plt Count
PT
PTT
Hct
Fibrinogen
ACT
Amicar
Mean Arterial Pressure
rFVIIa
Xa
Frequency
-PRN
Q 4 hours
Q 4 hours
Q 4 hours
Q 4 hours
Q 4 hours
Q 30 minutes
Consider
Continuously
Consider
BID
90
Range
0 - 60units/Kg/Hr
-> 150,000K/mm3
≤ 15 seconds
45-60 seconds
> 35%
> 200mg/dL
160-180 Seconds
100mcg/Kg load, 33mcg/Kg/hr drip
Low normal for age
30mcg/Kg/dose
0.3 - 0.4 units/mL
Bleeding > 10mL/Kg/hr:
Heparin - Heparin should remain at the current rate. Consider turning the heparin off, if the below are
ineffective. Amicar or rFVIIa administration is not recommended in the absence of heparin, due to the potential
for catastrophic circuit failure, but may be given in this state per attending physicians orders.
Thromboelastograph (TEG) - A TEG should be considered throughout the bleeding period. TEG results are
available ~45minutes after the sample is drawn and therefore treatment of the TEG results will lead to treatment
of historical values.
Platelet Count - Platelet counts should be assessed every four hours. The platelet goal is 150,000/mm3. Platelets
should be administered in quantities of 10mL/Kg in the neonatal and pediatric ECMO patients between (2-20Kg).
Patients > 20Kg will often require 1 or more units of platelets for adequate restoration of their functional platelet
counts. Recheck platelet count 30 minutes post administration.
Prothrombin Time (PT) - Assessed every fourt hours. The PT should remain ≤ 15 seconds. If greater than 15
seconds, treat with additional fresh frozen plasma (20mL/Kg for patients < 10Kg or 1 or more units for patients >
10Kg).
Partial Thromboplastin Time (PTT) - The normal ECMO patients PTT may be prolonged, dependent upon the
amount and timing of heparin administration. The PTT may start out prolonged and decrease over the hours to
days. The PTT should be checked every four hours. If the PTT is prolonged, consider decreasing the heparin rate.
If a heparin rate change or heparin bolus has been given, wait a minimum of three hours before checking the
PTT.
Hematocrit (Hct) - The CDI 500™ will be utilized to trend the patient’s Hct. It is therefore essential to calibrate the
CDI 500™ with any Hgb/Hct sample. The Hct goal will be >35%.
Fibrinogen - Assessed every four hours. The fibrinogen should be maintained above 200mg/dL. If less than
200mg/dL, treat with one unit of cryoprecipitate. If less than 150mg/dL, treat with two units of cryoprecipitate.
Activated Clotting Time (ACT) - The ACT should be monitored every 30 minutes. The range should be 160-180
seconds unless otherwise ordered by the physician.
Aminocaproic Acid (Amicar) - Amicar may be considered for this patient group. Follow Amicar policy regarding
dosage.
After the equivalent of two circulating blood volumes have been administered, and the above laboratory values are
within the set parameters reassessment of the bleeding must be undertaken. If the patient continues to bleed at
>10mL/Kg/hr, rFVIIa (NovoSeven, Factor VII) administration should be considered.
rFVIIa - Factor VII may be considered for this patient after all of the above coagulation parameters have been
met. A surgeon should be consulted prior to administering rFVIIa to eliminate bleeding that may be surgically
controllable.
Discontinue Amicar four hours prior to administering rFVIIa.
Factor VII will be administered to the ECMO circuit in 30mcg/Kg aliquots every 30 minutes x 3 as long as the
bleeding persists at > 10mL/Kg/hour or (>5mL/Kg/30minutes). If the bleeding decreases to <10mL/Kg/hour
between any aliquot, DO NOT ADMINISTER the next aliquot.
91
Prior to administering rFVIIa:
1) Notify the on-call perfusionist/ECMO primer
2) Prime a backup circuit with crystalloid to remain nearby.
Unfractionated Anti-Xa - The Xa level is generally only checked BID. Arrangements should be made with the
coagulation section of the laboratory to have the Xa level run BID on weekends and Holidays. The goal for the Xa
will be 0.3 - 0.4units/mL. Adjustments should be made based on the Xa chart located within the Heparin
management protocol. If a heparin rate change or heparin bolus has been given, wait a minimum of three
hours before checking the Xa level.
With the ECMO patient that is bleeding >10mL/Kg/hour, blood component administration should be administered at a
1:1:0.5 ratio. That is, for every 20mL/Kg of PRBC’s administered, there should also be 20mL/Kg of FFP and 10mL/Kg of
Platelets administered. This concurrent therapy is designed to more closely replace the whole blood that is being lost.
Cardiac Bleeding Protocol (>10mL/Kg)
Personnel: ECMO Specialist
Outcome: Attainment of hemostasis.
Note: Bleeding greater than 10mL/kg/hr in the cardiac patient will initiate the following protocol. Maintenance of the
below parameters may require running multiple blood components into the ECMO circuit concurrently. To accomplish
this, the ECMO specialist will connect the products to more than one pigtail within the circuit. It will also require the
ECMO specialist to be proactive and order blood components before the respective laboratory value is outside the set
parameters. Ordering of blood products will be based on the laboratory trends not the absolute value.
Management
FREQUENCY
RANGE
Heparin
OFF
OFF
TEG
Now
--
Functional Plt Count
Q2-4 hours
> 100,000 K/mm3
PT
Q2-4 hours
≤ 15 seconds
PTT
Q2-4 hours
< 60 seconds
Hct
Q2-4 hours
> 35%
Fibrinogen
Q2-4 hours
> 200mg/dL
Monitored every 30 minutes
--
Continuously
Low Normal for age
Q30 minutes x 3 (see below)
30mcg/Kg/dose
ACT
Mean Arterial Pressure
rFVIIa
92
Heparin - Heparin will not be given until there has been a four (consecutive) hour period without bleeding or
there are obvious signs of clot within the ECMO circuit. A full circuit check should be completed and documented
every 30 minutes while the heparin remains off.
Platelet Function - Platelet function will be assessed. The functional platelet goal is 100,000/mm3. Functional
platelet counts are available through the Cardiovascular Perfusion Department via the Helena ABX
PlateletWorks™ analyzer. Platelets should be administered in quantities of 10mL/Kg in the neonatal and
pediatric ECMO patients between (2-20Kg). Patients > 20Kg will often require 1 or more units of platelets for
adequate restoration of their functional platelet counts. Recheck platelet count 30 minutes post administration.
Prothrombin Time (PT) - Assessed Q two to four hours. The PT should remain ≤ 15 seconds. If greater than 15
seconds, treat with additional fresh frozen plasma (20mL/Kg for patients < 10Kg or 1 or more units for patients >
10Kg).
Partial Thromboplastin Time (PTT) - The PTT may be unusually short in this patient population due to limited
heparin therapy. The normal ECMO patients PTT may be greater than 80 seconds, dependent upon the amount
and timing of heparin remaining from the bypass period prior to initiation of ECMO support. The PTT may start
out prolonged and decrease over the next few hours. The PTT should be checked Q two to four hours. If the PTT
is prolonged, consider decreasing the heparin rate. If a heparin rate change or heparin bolus has been given,
wait a minimum of three hours before checking the PTT.
Thromboelastograph (TEG) - A TEG will be run as needed throughout the bleeding period. TEG results are
available ~45minutes after the sample is drawn and therefore treatment of the TEG results will lead to treatment
of historical values.
Hematocrit (Hct) - The CDI 500™ will be utilized to trend the patient’s Hct. It is therefore essential to calibrate the
CDI 500™ with any Hgb/Hct sample. The Hct goal will be >35%.
With the ECMO patient that is bleeding >10mL/Kg/hour, blood component administration should be administered at a
1:1:0.5 ratio. That is, for every 20mL/Kg of PRBC’s administered, there should also be 20mL/Kg of FFP and 10mL/Kg of
Platelets administered. This concurrent therapy is designed to more closely replace the whole blood that is being lost.
With large doses of blood preserved in CPD, or with large doses of FFP (also preserved with CPD) calcium chloride may
be needed in a ratio of 0.5mg calcium chloride to every 1 mL of blood product administered. To quantify this need an
hourly iSTAT CG8+ cartridge may be run.
After the equivalent of two circulating blood volumes have been administered, and the above laboratory values are
within the set parameters reassessment of the bleeding must be undertaken. If the patient continues to bleed at
>10mL/Kg/hr, rFVIIa (NovoSeven, Factor VII) will be administered.
rFVIIa - Factor VII will be administered to the ECMO circuit in 30mcg/Kg aliquots every 30 minutes x 3 as long as
the bleeding persists at > 10mL/Kg/hour or (>5mL/Kg/30minutes). If the bleeding decreases to <10mL/Kg/hour
between any aliquot, DO NOT ADMINISTER the next aliquot.
Prior to administering rFVIIa: 1) Notify the on-call perfusionist
2) Prime a backup circuit with crystalloid to remain nearby.
93
Four hours after the bleeding has stopped:
Heparin - Begin at 10units/Kg/hour. Monitor ACT every 15 – 30 minutes until stable, then every hour.
If ACT increases or decreases by more than 10% between samples, immediately redraw the ACT. If still
more/less than 10% of previous sample send PT/PTT and unfractionated anti Xa to laboratory.
Maintain the following as outlined above: PT, Functional platelet count, Hct, fibrinogen and MAP.
Unfractionated Anti-Xa - Sent BID daily, range 0.3-0.8 units/mL
Antithrombin III (ATIII) - Send daily. The ATIII level should be maintained at 100%. To accurately dose the ECMO
patient, the circuit volume must be considered. Because ATIII is dosed/Kg, for every 75mL of volume within the
ECMO circuit add an additional one Kg.
Example
ATIII laboratory result 55%, patient weighs 5Kg, circuit volume 419mL.
Dosing for the patient ONLY:
(100-55) x 5Kg = 225 units of ATIII needed
Dosing for the ECMO patient AND the ECMO circuit:
(100-55) x 12.8Kg = 576 units of ATIII needed
Patient Weight
1-10Kg
>10-20
>20-30Kg
>30Kg
Circuit Size
¼x¼
¼x⅜
¼x⅜
⅜x⅜
Circuit Volume
419 = 7.8Kg*
718 = 9.6Kg*
600 = 8Kg*
900 = 13.3Kg*
*Blue = Circuit volume mL’s converted to Kg weight for ATIII calculation
As you can see, not correcting for the ECMO circuit would lead to a grossly inadequate dose of ATIII.
94
Blood Products – Transfusion Services
Blood Product Administration – Packed Red Blood Cells (PRBC)
Chart 1
Patient Blood
Type
Compatible
RED BLOOD
CELLS
Compatible
PLATELETS
Compatible
PLASMA
Compatible
CRYO
O positive
O positive/negative
O, A, B, AB
positive/negative
O, A, B, AB
positive/negative
O, A, B, AB
positive/negative
A positive
A, O
positive/negative
A, AB
positive/negative
A, AB
positive/negative
A, AB
positive/negative
B positive
B, O
positive/negative
B, AB
positive/negative
B, AB
positive/negative
B, AB
positive/negative
AB positive
AB, A, B, O
positive/negative
AB positive/negative AB positive/negative
O negative
O
negative
O, A, B, AB negative
O, A, B, AB
positive/negative
O, A, B, AB
positive/negative
A negative
A, O
negative
A, AB
negative
A, AB
positive/negative
A, AB
positive/negative
B negative
B, O
negative
B, AB
negative
B, AB
positive/negative
B, AB
positive/negative
AB
negative AB positive/negative
AB negative
AB, A, B, O negative
95
AB
positive/negative
AB
positive/negative
Insert 1
All blood products must be checked and blood slips signed immediately upon arrival to the patient room.
96
Personnel: ECMO Specialist
Equipment:
Volume > 60mL (Bag from Blood bank)
Medfusion pump
Medfusion blood administration tubing (filtered)
Volume > 60mL (Bag from Blood bank) **Emergency Push**
60mL syringe
40µ filter and Hemotap or Medfusion blood tubing
3-way stopcock
Volume < 60mL (60mL syringe from Blood bank)
This product is pre-filtered, additional filtering is not required
Syringe pump
Syringe pump tubing (pressure tubing 24 or 36 inch)
Goal: Maintain hemoglobin (Hgb) and hematocrit (Hct) within prescribed ranges. More importantly, to optimize oxygen
delivery to the patient.
Dosing: PRBC’s should be administered in quantities of 20mL/Kg in the neonatal and pediatric ECMO patients between
(2-10Kg). Patients > 10Kg will often require 1 or more units of PRBC’s for adequate restoration of their Hgb.
Warning: Large quantities of PRBC administration may cause a sudden decrease in the patients Ca++ level and [BE], as well
as an increase in K+.
Review NCH Patient/Family Care Procedure, General Procedure #XI-45:07 prior to administering blood or
blood products to the ECMO patient.
Steps:
Volume > 60mL (Bag from Blood bank)
1. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
2) Donor # of product
3) Expiration of product
4) Temperature indicator (if applicable)
2.
3.
4.
5.
6.
Complete pre-administration documentation (Insert 1).
Connect medfusion blood administration tubing (filtered) to blood bag.
Prime tubing in an air-free manner.
Place tubing in medfusion pump, set rate and volume of blood to be delivered. Deliver over 30-60 minutes.
Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
97
7. Connect to the pre-oxygenator stopcock prepped in step 6 above, using an aseptic air-free connection
technique.
8. Open stopcock on ECMO circuit and begin blood delivery.
9. Complete post administration documentation (Insert 1).
Volume > 60mL (Bag from Blood bank) **Emergency Push**
1. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
2) Donor # of product
3) Expiration of product
4) Temperature indicator (if applicable)
2. Complete pre-administration documentation (Insert 1).
a. Connect 40µ filter and hemotap to the blood bag.
b. Draw blood into 60mL syringe.
c. Vigorously wipe any designated stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
d. Connect syringe to the designated stopcock prepped in step c above, using an aseptic air-free connection
technique.
e. Push blood into the pre-oxygenator port within the ECMO circuit ensuring air is not entrained with blood.
f. Repeat above steps (a-e) until desired quantity is administered.
or
a.
b.
c.
d.
Connect medfusion blood administration tubing (filtered) to blood bag.
Connect a 3-way stopcock to the free end of tubing.
Prime blood administration tubing in an air free manner including the stopcock.
Vigorously wipe any designated stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
e. In an aseptic manner, connect the stopcock to the stopcock prepped in step b above in an air-free manner.
f. Utilizing the 60mL syringe, pull blood from the bag into the syringe, change stopcock position to allow blood
to be pushed into the circuit in an air-free manner.
g. Repeat above steps (a-f) until desired quantity is administered.
Volume < 60mL (60mL syringe from Blood bank)
1. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
3) Donor # of product
4) Expiration of product
98
2.
3.
4.
5.
6.
Complete pre-administration documentation (Insert 1).
Connect syringe pump tubing (pressure tubing 24 or 36 inch).
Prime tubing in an air-free manner.
Place syringe into syringe pump, set rate and volume of blood to be delivered. Deliver over 15-30 minutes.
Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
7. Connect to the pre-oxygenator stopcock prepped in step 6 above, using an aseptic air-free connection technique.
8. Open stopcock on ECMO circuit and begin blood delivery.
9. Complete post administration documentation (Insert 1).
Blood Product Administration – Fresh Frozen Plasma (FFP, Plasma)
Personnel: ECMO Specialist
Equipment:
Volume > 60mL (Bag from Blood bank)
Medfusion pump
Medfusion blood administration tubing (filtered)
Volume < 60mL (60mL syringe directly from Blood bank)
This product is pre-filtered, additional filtering is not required
Syringe pump
Syringe pump tubing (pressure tubing 24 or 36 inch)
Goal:
Maintain circulating plasma levels within the patient. Maintain/increase clotting factors II (prothrombin), V
(proaccelerin), X (Stuart-Prower), XI (plasma thromboplastin), XII (Hageman) and XIII (fibrin-stabilizing) levels
within the patient.
Dosing:
FFP should be administered in quantities of 20mL/Kg in the neonatal and pediatric ECMO patients between (210Kg). Patients > 10Kg will often require 1 or more units of FFP for adequate restoration of their clotting cofactors.
FFP should be administered following every PRBC treatment or at a maximum after every two PRBC
treatments. This will help ensure the correct ratio of plasma to red blood cells is maintained, and assist with
coagulation / anticoagulation.
Note:
FFP is a poor choice for the replacement of Antithrombin (ATIII). If a patient has an identified ATIII
deficiency, they should be treated with ATIII, not FFP.
Review NCH Patient/Family Care Procedure, General Procedure #XI-45:07 prior to administering blood or
blood products to the ECMO patient.
Steps:
Volume > 60mL (Bag from Blood bank)
99
1. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
2) Donor # of product
3) Expiration of product
2.
3.
4.
5.
6.
Complete pre-administration documentation (Insert 1).
In an aseptic manner, connect medfusion blood administration tubing (filtered) to FFP bag.
Prime tubing in an air-free manner.
Place tubing in medfusion pump, set rate and volume of FFP to be delivered. Deliver over 30-60 minutes.
Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
7. Connect to the pre-oxygenator stopcock prepped in step 6 above, using an aseptic air-free connection technique.
8. Open stopcock on ECMO circuit and begin FFP delivery.
9. Complete post administration documentation (Insert 1).
Volume < 60mL (60mL syringe from Blood bank)
1.
Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
2) Donor # of product
3) Expiration of product
2.
3.
4.
5.
6.
Complete pre-administration documentation (Insert 1).
Connect syringe pump tubing (pressure tubing 24 or 36 inch) to FFP syringe.
Prime tubing in an air-free manner.
Place syringe into syringe pump, set rate and volume of FFP to be delivered. Deliver over 15-30 minutes.
Vigorously wipe any pre-oxygenator stopcock/pigtail interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
7. Connect to the pre-oxygenator stopcock prepped in step 6 above, using an aseptic air-free connection technique.
8. Open stopcock on ECMO circuit and begin FFP delivery.
9. Complete post administration documentation (Insert 1).
Blood Product Administration – Platelets
Personnel: ECMO Specialist
Equipment:
Volume > 60mL (Bag from Blood bank)
Medfusion pump
Medfusion blood administration tubing (filtered)
Volume < 60mL (60mL syringe from Blood bank)
This product is pre-filtered, additional filtering is not required
Syringe pump
100
Syringe pump tubing (pressure tubing 24 or 36 inch)
Goal:
Maintain patient platelet count within the prescribed range. Platelets are fundamental in the formation and
maintenance of clot. In the presence of decreased platelet numbers or function, bleeding may occur.
Dosing: Platelet trends should be monitored closely. As the platelet count approaches the lower limit of the prescribed
range, administration should occur. The ECMO specialist should not wait until the lower limit has been
breached to administer platelets unless specifically ordered to wait by the physician.
Platelets should be administered in quantities of 20mL/Kg in the neonatal and pediatric ECMO patients
between (2-20Kg). Patients > 20Kg will often require 1 or more units of platelets for adequate restoration of
their platelet counts.
Prior to scheduled surgery, it is recommended that the patient platelet count be increased to 150,000/mm 3,
and maintained at this level for 72-96 hours post operatively. Each milliliter of platelets contains ~ 1,000,000
platelets.
While on ECMO, the recommended platelet goal is 100,000K/mm3 unless otherwise ordered by the attending
physician.
Review NCH Patient/Family Care Procedure, General Procedure #XI-45:07 prior to administering blood or
blood products to the ECMO patient.
Steps:
Volume > 60mL (Bag from Blood bank)
1. If possible, Platelets should be given directly to the patient instead of ECMO circuit.
2. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
2) Donor # of product
3) Expiration of product
4) Temperature indicator (if applicable)
3. Complete pre-administration documentation (Insert 1).
4. Administer a ½ hour heparin bolus from vial or syringe, not heparin bag. This bolus is necessary as heparin binds
to platelets.
5. Check ACT now and every 15 minutes throughout platelet administration and 15 minutes post administration.
6. In an aseptic manner, connect medfusion blood administration tubing (filtered) to platelet bag.
7. Prime tubing in an air-free manner.
8. Place tubing in medfusion pump, set rate and volume of platelets to be delivered. Deliver over 30-60 minutes.
9. Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
101
10. Connect to the pre-oxygenator stopcock prepped in step 9 above, using an aseptic air-free connection
technique.
11. Open stopcock on ECMO circuit and begin platelet delivery.
12. Complete post administration documentation (Insert 1).
13. Recheck platelet count 30 minutes post administration.
Volume < 60mL (60mL syringe from Blood bank)
1. Check blood product at bedside with another qualified individual per hospital policy.
To include:
1) Patient identification
2) Confirm compatibility (Chart 1)
3) Donor # of product
4) Expiration of product
2. Complete pre-administration documentation (Insert 1).
3. Administer a ½ hour heparin bolus from vial or syringe, not heparin bag. This bolus is necessary as heparin binds
to platelets.
4. Check ACT now and every 15 minutes throughout platelet administration and 15 minutes post administration.
5. In an aseptic manner, connect syringe pump tubing (pressure tubing 24 or 36 inch) to platelet syringe.
6. Prime tubing in an air-free manner.
7. Place syringe into syringe pump, set rate and volume of platelets to be delivered. Deliver over 15-30 minutes.
8. Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
9. Connect to the pre-oxygenator stopcock prepped in step 8 above, using an aseptic air-free connection
technique.
10. Open stopcock on ECMO circuit and begin platelet delivery.
11. Complete post administration documentation (Insert 1).
12. Recheck platelet count 30 minutes post administration.
Blood Product Administration – Cryoprecipitate (Cryo)
Personnel: ECMO Specialist
Equipment:
Volume < 60mL (Delivered in a 60mL syringe from Blood bank)
This product is pre-filtered, additional filtering is not required
Syringe pump
Syringe pump tubing (pressure tubing 24 or 36 inch)
Goal:
Increase circulating fibrinogen levels > 150mg/dL, treatment of hemophilia and von Willebrand’s disease. Cryo
is abundant in factors; I (Fibrinogen), VIII (anti-hemophilic factor A), XIII (Fibrin stabilizing factor) and vWF (von
Willebrand Factor).
Dosing:
Fibrinogen level
Treatment
102
< 50mg/dL
2 units/10Kg
(average volume per unit = 7-10mL)
< 100mg/dL
1 units/10Kg
(average volume per unit = 7-10mL)
Typical maximum adult dose is ~ 4 units which should raise the adult patient’s fibrinogen 30-60mg/dL.
A fibrinogen level greater than 150mg/dL is desirable in all ECMO patients, but is vital in patients on ECMO
about to undergo surgery.
Steps:
Volume < 60mL (Delivered in a 60mL syringe from Blood bank)
1. If possible, Cryo should be given directly to the patient instead of ECMO circuit.
2. Check blood product at bedside with another qualified individual per hospital policy.
To include:
3.
4.
5.
6.
7.
8.
9.
10.
1. Patient identification
2. Confirm compatibility (Chart 1)
3. Donor # of product
4. Expiration of product
Complete pre-administration documentation (Insert 1).
In an aseptic manner, connect syringe pump tubing (pressure tubing 24 or 36 inch) to cryoprecipitate syringe.
Prime tubing in an air-free manner.
Place syringe into syringe pump, set rate and volume of Cryo to be delivered. Deliver over 15-30 minutes.
Vigorously wipe any pre-oxygenator stopcock/cap interface with alcohol pad for 15 seconds, then wipe
stopcock/cap interface with second alcohol pad. Allow to dry for 30 seconds.
Connect to the pre-oxygenator stopcock prepped in step 7 above, using an aseptic air-free connection
technique.
Open stopcock on ECMO circuit and begin Cryo delivery.
Complete post administration documentation (Insert 1).
Medications
Heparin Infusion, Xa - Administration & Management
Personnel: ECMO Specialist
Equipment:
Medfusion pump
Medfusion tubing
ECMO heparin bag D5 (concentration 100 units Heparin/ml)
103
Outcome:
Maintain patient anticoagulation parameters within ordered/acceptable ranges as defined by the
patient condition and specified physician parameters.
Goal ACT Range: 180-220 seconds (or per physician order)
PTT Range:
60-90 seconds (or per physician order)
Normal ECMO Anti-Factor Xa Range:
0.3 – 0.8 u/ml (blue top 2.7ml tube)
Steps:
1. Verify heparin infusion/ordered ACT and PTT range at each shift change or when changing bag.
2. Send Anti-Factor Xa to coag lab BID (or per physician order)
Ensure heparin is at steady state prior to sending lab. i.e. no drip changes or boluses in previous three
hours.
3. When changing bag and tubing, ensure ALL air is removed from tubing prior to connecting to the ECMO circuit.
4. Heparin infusion site is between the bridge and the bladder, or for centrifugal circuits will be post disposable
centrifugal pump.
5. Perform ACTs per protocol every hour unless ACT is unstable or platelets or Antithrombin III (also known as ATIII or
Antithrombin) are infused. Then run ACT every 15-30 minutes until stable within ordered range.
When infusing platelets, administer a heparin bolus (equivalent to ½ the current hourly heparin drip i.e.
current rate 20 units/Kg/hr, Patient weighs 5Kg = 100units/hr, administer ½ x 100units = 50 unit bolus) prior
to beginning platelet infusion. Repeat ACT every 15-30 minutes during infusion and 30 minutes post
transfusion
6. Titration/Initiation of heparin infusion:
Begin Heparin infusion (20 units/Kg/hr) when ACT is < 240 seconds.
Check ACT every 15 minutes until stable and within ordered range.
ONCE WITHIN RANGE:
ACT is within range – no change in rate, check ACT every hour.
Notify ECMO physician if rate drops to 10 units/kg/hr or is greater than 60 units/kg/hr.
Do not run heparin rate less than 10 units/kg/hr unless ordered by ECMO physician.
CORRECTIVE ACTIONS FOR “OUT OF RANGE” ACT’s on ECMO patients:
ACT out of range low – Verify bag concentration/confirm rate.
* Trace heparin infusion to patient to ensure connection
Review medical chart, specifically the most recent Anti-Factor Xa level and refer to chart chart 1 below.
Repeat ACT, if second ACT is out of range low, then:
Administer a heparin bolus (equivalent to the current hourly heparin drip), repeat ACT in 15 minutes.
ACT remains out of range low – give a second one-hour bolus, repeat ACT in 15 minutes.
After two one-hour boluses, if ACT remains low, increase heparin rate by 10%, then give a third onehour bolus. Repeat ACT in 15 minutes.
If after three heparin boluses and a 10% increase in the heparin rate the ACT remains low, notify the
ECMO Primer (Perfusionist on call if cardiac ECMO patient) and ECMO physician.
Consider running an Anti-Factor Xa, PTT and ATIII level. (If needed contact Dr. Kathleen Nicol)
Verify urine output, as large increases in urine output will acutely decrease circulating heparin,
which will in turn decrease the ACT.
104
All heparin boluses are to be given from single dose vials. DO NOT BOLUS HEPARIN VIA THE
MEDFUSION PUMP.
Above sequence not to be repeated more often than every twelve hours without notifying the ECMO
physician.
ACT out of range high – Verify bag concentration/confirm rate.
Repeat ACT, if second ACT is also out of range high, then:
Decrease heparin rate by 10%, repeat ACT in 30 minutes.
ACT remains out of range high after 30 minutes, decrease rate by 10%, repeat ACT in 30 minutes.
If after two 10% rate reductions the ACT remains out of range high, notify the ECMO primer
(Perfusionist on call if cardiac ECMO patient) and physician.
Run PTT and FDP/FSP levels.
Consider running an Anti-Factor Xa level.
DIC may cause an elevated ACT in the presence of sub-therapeutic heparin levels.
Verify urine output, as anuria may cause the ACT to increase.
Unexpected out of range high or low ACT – immediately repeat ACT
Chart 1
Response to Anti-factor Xa Activities PTT and ACT values
Anti-factor Xa
PTT
ACT
Response
(0.3-0.8 u/ml)
1. Repeat anti-Factor Xa, PTT, ACT
2. Consider FDP/FSP to rule out DIC
3. Check pt. temperature
normal
4. Rule out hemodilution
5. If at upper end of Anti-Xa range, consider decreasing
Heparin drip rate by 5-10%.
1. Consider checking ATIII and Fibrinogen level
2. Administer FFP 20ml/Kg or ATIII, then repeat anti-Factor Xa
normal
level
3. Increase heparin drip rate by 10%
1. Consider checking ATIII level
2. Repeat anti-factor Xa, PTT and ACT at this time
normal
3. If at upper end of Anti-Xa range, consider decreasing
Heparin drip rate by 5-10%.
1. Decrease heparin drip rate by 10%
1.
2.
3.
1.
2.
1.
2.
3.
Consider checking ATIII level
Administer FFP/ATIII (preferably ATIII)
Decrease heparin drip rate by 5-10%
Consider Heparin Bolus
Increase heparin drip rate by 10%
Consider Heparin bolus
Consider FDP/FSP to rule out DIC
Increase Heparin drip rate by 5%
105
Medication Administration – Epsilon-Aminocaproic Acid (Amicar)
Personnel:
ECMO Specialist
Equipment:
IV pump and tubing
Amicar bag from pharmacy
Personnel protective equipment
Alcohol prep pads
Additional references: Patient/Family policy section 035-medication
Pharmacy-drug cards
Indications: Suspected or confirmed fibrinolysis. Patients on ECMO requiring surgery may be pre-treated with amicar.
Outcome:
Amicar is an anti-fibrinolytic or anti-proteolytic, that binds to plasminogen and blocks the binding of fibrin.
By binding the plasminogen, Amicar reduces plasminogens conversion to plasmin, the primary means of
clot lysis.
Warning: May cause thrombosis of circuit and cannula.
Continuation of anticoagulation is recommended.
Goal: Control of fibrinolysis.
Dosing calculation: Loading dose - 100mg/Kg Administered over one hour
* Loading dose should be finished 30-60 minutes prior to surgical incision.
Maintenance - 33.3 mg/Kg/hr continuous infusion for 3-5 days or per physicians order
Maximum dose = 30grams/day
Steps:
1.
2.
3.
4.
Verify: patient name, patient allergies, medication, dose, route, physician order and expiration of syringe.
Apply personnel protective equipment.
Connect to medication bag, prime tubing and ensure air is removed from tubing.
Vigorously wipe a pre-oxygenator stopcock/pigtail interface with alcohol pad for 15 seconds, then wipe
stopcock/pigtail interface with second alcohol pad. Allow to dry for 30 seconds.
5. Aspirate 1mL waste from ECMO circuit pigtail to which tubing will be connected.
6. Connect tubing to stopcock in such a manner as to avoid air within the connection.
106
7.
8.
9.
10.
Set pump to deliver Amicar loading dose over 60 minutes.
Perform ACTs hourly or per physician order.
Once the loading dose is complete, begin maintenance infusion per physician order.
Record administration on patient medical record.
Medication Administration – Antithrombin (ATIII)
Personnel: ECMO Specialist
Equipment:
Syringe pump
Micro tubing
Antithrombin syringe from pharmacy
Personnel protective equipment (PPE)
Alcohol prep pads
Additional references: Patient/Family policy section 035-medication
Pharmacy-drug cards
Indications: Low circulating ATIII levels, declining ACT values despite normal Xa levels.
Outcome: Restoration of circulating ATIII levels within the ECMO patient. Provide adequate quantity of ATIII so that, in
the presence of heparin, ATIII will bind with thrombin at a significantly increased rate to form thrombinAntithrombin complexes, thereby deactivating the thrombin and assisting with anticoagulation.
Goal: 80 – 100% (or per physician order)
Dosing calculation: (100% - (actual patient %)) * wt in kg = units to administer
To accurately dose the ECMO patient, the circuit volume must be considered. Because ATIII is dosed/Kg, for every
75mL of volume within the ECMO circuit add an additional one Kg. The average ECMO circuit is ~660mL, therefore as
an average; an additional ~8.8Kg can be added to the patient’s weight for calculating this medication. To assess the
response the patient has had to an ATIII dose, draw an ATIII level 60 minutes post administration, and again at 24
hours post administration. This will allow the ECMO physician to calculate the frequency and quantity of future ATIII
doses.
Example
ATIII laboratory result 55%, patient weighs 5Kg, circuit volume 419mL (from below chart).
Dosing for the patient ONLY:
(100-55) x 5Kg = 225 units of ATIII needed
107
Dosing for the ECMO patient AND the ECMO circuit:
(100-55) x 12.8Kg = 576 units of ATIII needed
Patient Weight
1-10Kg
>10-20
>20-30Kg
>30Kg
Circuit Size
¼x¼
¼x⅜
¼x⅜
⅜x⅜
Circuit Volume
419 = 7.8Kg*
718 = 9.6Kg*
600 = 8Kg*
900 = 13.3Kg*
*Blue = Circuit volume mL’s converted to Kg weight for ATIII calculation
As you can see, not correcting for the ECMO circuit would lead to a grossly inadequate dose of ATIII.
Steps:
1.
2.
3.
4.
Verify: patient name, patient allergies, medication, dose, route, physician order and expiration of syringe.
Apply personnel protective equipment.
Connect syringe and micro tubing, ensure air is removed from syringe and tubing.
Vigorously wipe a pre-oxygenator stopcock/pigtail interface with alcohol pad for 15 seconds, then wipe
stopcock/pigtail interface with second alcohol pad. Allow to dry for 30 seconds.
5. Aspirate 1mL waste from ECMO circuit pigtail to which tubing will be connected.
6. Connect tubing to stopcock in such a manner as to avoid air within the connection.
7. Set syringe pump to deliver ATIII over 10-20 minutes.
RATE NOT TO EXCEED 100units/minute
8. Perform ACTs during AT III administration every 15 minutes, and once 15 minutes post ATIII administration, or
per physician order.
9. Once the infusion is complete, remove micro tubing, clean stopcock with alcohol prep pad, slowly flush pigtail
with 2mL of ECMO flush.
10. Record administration on patient medical record.
Medication Administration – rFVIIa (NovoSeven, Factor VII)
Personnel:
ECMO Primer
Perfusionist
Equipment:
Syringe pump
Syringe pump micro tubing
rFVIIa syringe from pharmacy
Personnel protective equipment
Alcohol prep pads
Backup circuit crystalloid primed at bedside prior to administration
108
Additional references: Patient/Family policy section 035-medication
Pharmacy-drug cards
Indications: Intractable bleeding (off-label use) that is not responding to typical medical
management (refer to hemorrhage protocol), Factor VII deficiency.
Outcome: Administration of rFVIIa leads to the binding of FVIIa to tissue factor (Factor III). This action is then followed
by the activation of clotting factors Christmas and Stuart-Prower (IX, X) and ultimately to the conversion of
prothrombin (factor II) into thrombin. Thrombin then activates platelets and factors V and VII (Proaccelerin
and proconvertin) at the site of tissue injury. This activation will potentially lead to the formation of a
haemostatic plug and further reinforcement of this plug by the conversion of fibrinogen (factor I) into fibrin.
Warning: May cause sudden, acute thrombosis of circuit and cannula.
Goal: Hemorrhage control
Dosing calculation: 90µcg/Kg
Give 1/3 of dose (30µcg/Kg), followed in 30 minutes by the second 1/3 of the dose (30µcg/Kg),
followed in 30 minutes by the final 1/3 of the dose (30µcg/Kg) for a total of 90µcg/Kg or per
physicians order.
Steps:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Verify: patient name, patient allergies, medication, dose, route, physician order and expiration of syringe.
Apply personnel protective equipment.
In an aseptic manner, connect syringe and micro tubing, ensure air is removed from syringe and tubing.
Vigorously wipe a pre-oxygenator stopcock/pigtail interface with alcohol pad for 15 seconds, then wipe
stopcock/pigtail interface with second alcohol pad. Allow to dry for 30 seconds.
Aspirate 1mL waste from ECMO circuit pigtail to which tubing will be connected.
In an aseptic manner, connect tubing to stopcock in such a manner as to avoid air within the connection.
Set syringe pump to deliver each aliquot of rFVIIa over 2-5 minutes.
Perform ACTs immediately after rFVIIa administration and every 15 minutes for one hour post administration, or
per physician order.
Once the infusion is complete, remove micro tubing, clean stopcock with alcohol prep pad, slowly flush pigtail
with 2mL of ECMO flush.
Record administration on patient medical record.
Perform PT, PTT, INR, Plt count, fibrinogen and other laboratory analysis per physician order.
Medication Administration – Argatroban
Personnel:
Perfusionist; ICU attending physician; ECMO primer
109
Equipment:
Syringe pump
Syringe pump micro tubing
Argatroban syringe from pharmacy
PPE
Alcohol prep pads
Additional references:
Patient/Family policy section 035-medication
Pharmacy-drug cards
Indications: Provide anticoagulation in patients with confirmed or suspected heparin-induced thrombocytopenia (HIT)
with or without Thrombosis (HITT).
Outcome:
Administration of Argatroban results in the inhibition of both bound and circulating thrombin leading to
anticoagulation. Argatroban is a direct thrombin inhibitor, and is monitored with PTTs as well as ACTs.
Note:
Patients with suspected HIT/T should have laboratory testing performed to support this
clinicopathologic diagnosis. HIT/T testing is available at NCH, M-F, 8am-4pm. Blood should be sent to the
lab in a 3mL red top tube.
There is no commercially available reversal agent for Argatroban. Administration may cause severe
hemorrhage. The T1/2 for Argatroban is approximately 45 minutes.
WARNING:
Argatroban is cleared through the hepatic system. Hepatic dysfunction may/will increase the time
required to clear Argatroban.
Pre-ECMO - (Known HIT positive patient)
Pre-ECMO pt. bolus:
100mcg/Kg (administered over 3-5min.) 30 minutes prior to ECMO initiation.
Pre-ECMO infusion:
2mcg/Kg/min begin infusion immediately after bolus ~ 30 minutes prior to ECMO
initiation.
ECMO Circuit:
100mcg/250mL of circuit prime administer to circuit 30 minutes prior to initiation.
*****************ADD CaCl to circuit with initiation of ECMO support**************
Conversion - (Patient on Heparin on ECMO changing to Argatroban)
With Circuit change:
Pt. bolus:
100mcg/Kg (administered over 3-5min.) 30 minutes prior to change out
*Discontinue heparin to circuit immediately prior to administering Argatroban
Pt. Infusion:
2mcg/Kg/min infusion started immediately after bolus, approximately 30 minutes prior to circuit change
out
Circuit bolus:
bolus to patient
100mcg/250mL of circuit prime administered 30 minutes prior to circuit change out.
***************ADD CaCl to circuit with initiation of ECMO Support***************
110
Without Circuit Change:
Pt. Bolus:
100mcg/Kg (administered over 3-5min.)
Pt Infusion:
1mcg/Kg/min infusion started immediately after bolus
* Discontinue heparin to circuit immediately prior to administering bolus to patient.
In all above scenarios, once on Argatroban:
Immediately discontinue all heparin exposure.
1. Remove ECMO (heparin) flushes from bedside, and replace with NaCl pre-filled
syringes.
2. Discontinue heparin in all IV fluids and arterial line(s)
3. Remove heparin syringes and vials from ECMO cart
4. Flush circuit pigtails (excluding post oxygenator) with NaCl every two hours
Monitoring:
Check PTT Q1 hour until stable. PTT Goal = 70-100 seconds
Once four consecutive PTT results are within ordered range, check PTT Q2 hours
If a PTT result comes back out of range (high or low) begin/continue checking PTT Q1
until four consecutive results are once again within range.
Check ACT Q1 hour (Range: 160 - 260seconds) The ACT is utilized as a trending device, and
therefore, adjustments in Argatroban are made based on the PTT, not the ACT.
Management:
If PTT is out of range high (> 100 seconds):
1. Decrease Argatroban infusion by 20%.
2. Allow steady state (minimum: two hours post infusion change) prior to making an
additional rate change.
3. Recheck PTT Q1 hour until four consecutive results are within ordered range.
If PTT is out of range low (< 70 seconds):
1. Increase Argatroban infusion by 20%.
2. Allow steady state (minimum: two hours post infusion change) prior to making an
additional rate change.
3. Recheck PTT Q1 hour until four consecutive results are within ordered range.
*Notify perfusionists on call if two consecutive PTT results are out of range*
DO NOT administer an Argatroban bolus with the administration of FFP, Platelets, Cryo, or PRBC’s.
111
MEDICATION RECOMMENDATIONS FOR THE ECMO PATIENT
1. Please consider the differences between a “new” circuit and an “old” circuit. New circuits have many sites
available for drug binding, where as old circuits will have most of their binding sites saturated and therefore
more drug will be available to the patient as the circuit ages. There is no specific time a circuit becomes “old”,
and each drug will respond differently. Keeping this in mind:
Drug
Phenytoin
Vancomycin
Morphine
Phenobarbital
Gentamicin
Pre membrane/post
membrane concentration
difference (NEW)
43% ↓
36% ↓
40% ↓
17% ↓
10% ↓
Pre membrane/post
membrane concentration
difference (OLD)
No loss
11% ↓
16% ↓
6% ↓
No loss
Table 1
2. The patient’s volume of distribution is likely to dramatically change after they have been attached to an ECMO
circuit. If the patient is on an aminoglycoside, please obtain 2 hour and 12 hour post dose levels (if dosing interval is
shorter than 12 hours, obtain a pre-dose level) empirically for pharmacokinetic evaluation.
3. When using benzodiazepines for sedation, the following has been reported:2
Diazepam – 88% reduction of drug levels
Midazolam – 68 % reduction of drug levels
Lorazepam – 40% reduction of drug levels
Consider lorazepam the benzodiazepine of choice for patients on ECMO.
4. When using opioids for analgesia, the following has been reported:
Increased need for opioids while on ECMO has been reported. It is not completely clear if this is due to
tolerance or binding to the circuit.3
Fentanyl is known to possess significantly more binding to the ECMO circuit, particularly to the tubing. Up to a
86% reduction in fentanyl levels has been observed within 120 minutes of administration during in vitro testing.4
Doses as high as 50 micrograms/kg/hour have been reported as being necessary.5
Consider morphine the preferred opioid for use while on ECMO, and reserving fentanyl only for rare cases.
5. Furosemide – 63-87% reduction in serum concentration over 4 hr. Loss is most pronounced in first 30 min after
admin.3 Recommend increasing dose to 2 mg/kg if desired response not achieved with initial dose of
furosemide.
References:
1. Table 1: Dagan O, Klein J, Gruenwald C, et al. Preliminary studies of the effects of extracorporeal membrane
oxygenator on the disposition of common pediatric drugs. Ther Drug Monit 1993;15:263-6.
2. Mulla H, Lawson G, von Anrep C, et al. In vitro evaluation of sedative drug losses during extracorporeal
membrane oxygenation. Perfusion 2000;15:21-6
3. Buck M. Pharmacokinetic changes during extracorporeal membrane oxygenation. Clin Pharmacokinet
2003;42(5):403-417
4. Preston T, Hodge A, Riley J, et al. In-vitro drug adsorption and plasma hemoglobin levels associated with hollow
fiber oxygenators in the extracorporeal life support (ECLS) circuit. JECT. 2007;39:234-237.
5. Arnold JH, Truog RD, Orav EJ, et al. Tolerance and dependence in neonates sedated with fentanyl during
extracorporeal membrane oxygenation. Anesthesiology 1990;73:1136-40
112
MEDICATIONS NOT APPROVED FOR ECMO ADMINISTRATION
The Pharmacy and Therapeutics Committee has approved the following list of medications as NOT to be administered
into the ECMO circuit.
Drug
Erythromycin
Ergotamine
Propofol
Rationale
Incompatible with heparin at low concentrations
Incompatible with heparin at low concentrations
Significant (98%) loss of drug due to binding with tubing
Reference
1
1
2, 3
ECMO certified specialists are not able to administer medications in which administration is restricted to an authorized
practitioner or CRNA. This includes:
Propofol
Ketamine
References:
1. Trissle’s
2. Mulla H, Lawson G, von Anrep C, et al. In vitro evaluation of sedative drug losses during extracorporeal
membrane oxygenation. Perfusion 2000;15:21-6
3. Buck M. Pharmacokinetic changes during extracorporeal membrane oxygenation. Clin Pharmacokinet
2003;42(5):403-417
113
Laboratory
Performing Activated Clotting Time Test (ACT)
Personnel:
ECMO Specialist
Equipment:
Hemochron Response
Hemochron ACT +/LR cuvette
PPE
1mL Syringe
Sterile 3 mL syringe
Alcohol Pad
Note:
ALL ACT samples will be drawn from the designated ACT port regardless if the bridge is OPEN or CLOSED.
Additional Reference: Hemochron Response User’s Manual; Point of Care Testing
Policy- POCT- P214 ACT 27
Steps:
1. Apply PPE.
2. Vigorously wipe stopcock/syringe interface with alcohol for 15 seconds, wipe stopcock/syringe interface with second
alcohol pad and allow to dry for 30 seconds. Then remove 1.0 ml of blood from the circuit. Close stopcock.
3. Discard waste syringe into biohazard container.
114
4. Attach 1mL syringe, open stopcock & withdraw 0.4 mL’s of blood. Do not allow bubbles to enter syringe. Close
stopcock.
5. Immediately press “Start” on the test well which will be utilized for testing.
6. Immediately place 0.4mL of blood into the P214 ACT test tube. Close the flip-top and mix the contents of the
test tube by holding the test tube in an upright position with thumb and forefinger, mix blood and activator by
gently flicking the bottom of the tube with remaining fingers
7. Insert the P214 tube into the Hemochron test well and quickly rotate one complete turn clockwise.
8. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
9. Attach new 3mL syringe to stopcock.
10. Record result and adjust heparin infusion if required per protocol. Record total out for I&Os.
11. Discard tube in biohazard container prior to running next ACT.
115
Laboratory Tests, Tube Colors and Volumes
116
117
118
Drawing Blood Cultures
Personnel: ECMO Specialist
Equipment:
PPE
Sterile appropriate size syringe for culture to be drawn
4 ea Alcohol prep pads
5mL ECMO flush syringe or 3mL empty syringe
Two-way Stopcock
Culture and/or isolator bottles
Necessary labels
Outcome: Removal of a blood sample that is representative of the patients/circuits current microbial/viral status.
Note: The circuit is at times under very negative or extremely positive pressure. It is imperative you understand
which type of pressure you will be subject to prior to entering the ECMO circuit.
Steps:
1. Apply PPE
2. Vigorously wipe stopcock/pigtail interface with alcohol pad for 15 seconds, then wipe stopcock/pigtail interface
with second alcohol pad. Allow to dry for 30 seconds.
3. Clamp designated pigtail and carefully remove existing stopcock.
4. Wipe open pigtail with alcohol pad. Allow to dry for 30 seconds.
5. Attach new sterile stopcock and close to the circuit.
6. Attach luered syringe, then remove clamp. Open stopcock and remove 1mL of waste.
7. Discard waste syringe into biohazard container.
8. Attach appropriate size syringe, open stopcock & withdraw quantity of blood needed. Close stopcock.
9. Wipe open port with alcohol pad. Allow to dry for 30 seconds.
10. Attach new 5mL ECMO flush syringe, open stopcock & flush pigtail/port with 1mL of ECMO flush or attach empty
3mL syringe to stopcock.
11. Label culture/isolator bottle with :
Patient laboratory label
Employee number
Date drawn
Time drawn
Source
119
Cannulae
Biomedicus Arterial Cannulae
Choosing the proper cannulae:
Example:
The goal flow has been determined to be 1.5L/min.
The correct cannula is therefore the 12Fr cannulae. At a flow of 1.5L/min the pressure loss through this cannulae
is roughly 60mmHg.
Choosing the 14Fr cannulae would also allow a flow of 1.5L/min at less than 100mmHg of pressure loss, but this
cannulae maybe too large for the vessel to accommodate.
Note: At the discretion of the surgeon, a small metallic clip may be placed at the intersection of the cannula and
its insertion into the corresponding vessel. The metallic clip may then be utilized as a reference point by
radiology to assist with determining the cannulaes position relative to the insertion point. The tip of this
cannulae is 4cm past the wire wrapping.
120
Choosing the proper cannulae:
Example:
The goal ARTERIAL flow has been determined to be 4L/min.
The correct cannula is therefore the 17Fr biomedicus cannulae or larger. At a flow of 4L/min the pressure loss
through this cannulae is roughly 100mmHg.
Choosing the 15Fr cannulae would not allow a flow of 4L/min at less than 100mmHg of pressure loss, therefore
this cannulae would not be an acceptable alternative.
The goal VENOUS flow has been determined to be 4L/min.
The correct cannula is therefore the 23Fr biomedicus cannulae. At a flow of 4L/min the pressure loss through
this cannulae is roughly 20mmHg.
If presented with the above scenario, the surgeon should be made aware that one cannula may not provide
enough venous return, and that a second venous cannula may be necessary.
121
Bio-Medicus
One Piece
Arterial
Cannula
Non-vented
96820008, 010, 012, 014Fr
No side holes, minimal
extension from
radiopaque portion
Bio-Medicus
One Piece
Arterial
Cannula
15F
96530015, 017, 019, 021Fr
Side holes extend 4 cm
from wire wrapping
NO radiopaque
marker at tip!
122
21F
Biomedicus Venous Cannulae
Note: At the discretion of the surgeon, a small metallic clip may be placed at the intersection of the cannula and its
insertion into the corresponding vessel. The metallic clip may then be utilized as a reference point by radiology to assist
with determining the cannulaes position relative to the insertion point. The tip of this cannulae is marked by a
radiopaque dot.
Choosing the proper cannulae:
Example:
The goal flow has been determined to be 0.5L/min.
The correct cannula is therefore the 10Fr cannulae. At a flow of 0.5L/min the pressure loss through this cannulae
is roughly 20mmHg.
Choosing the 12Fr or 14Fr cannulae would also allow a flow of 0.5L/min at less than 20mmHg of pressure loss,
but these cannulae maybe too large for the vessel to accommodate.
123
Note: At the discretion of the surgeon, a small metallic clip may be placed at the intersection of the cannula and its
insertion into the corresponding vessel. The metallic clip may then be utilized as a reference point by radiology to assist
with determining the cannulaes position relative to the insertion point. The tip of this cannulae is 4cm past the wire
wrapping.
Choosing the proper cannulae:
Example:
The goal flow has been determined to be 4L/min.
The correct cannula is therefore the 29Fr cannulae. At a flow of 4L/min the pressure loss through this cannulae
is roughly 20mmHg.
If presented with the above scenario, the surgeon should be made aware that one cannula may not provide
enough venous return, and that a second venous cannula may be necessary.
124
Bio-Medicus
One Piece
Venous
Cannula
96830008, 010, 012, 014Fr
Side holes extend
from wire wrapping
portion to radiopaque
dot at tip
17Fr
Bio-Medicus One
Piece Cannula
96670015, 017, 019, 021, 023Fr
No radiopaque
marker at tip!
25Fr
Bio-Medicus
One Piece
Cannula
96370023, 025, 027, 029Fr
No radiopaque
marker at tip!
Side holes extend 4 cm
from wire wrapping
125
Side holes extend 4 cm
from wire wrapping
VA Cannulae Flow Charts
Note: The following cannulae information is available in pdf format at www.medtronic.com. The flow charts listed below
were created by pumping room temperature water through the corresponding cannulae and should be considered the
best possible flow rates one may achieve with the respective cannulae.
126
VV Cannulae
Veno-Venous ECMO may be performed with a single dual lumen cannulae (pictured above) or with multiple site
cannulation. If utilizing the above dual lumen cannulae, cannulae size and placement should be based on the following
graphs (1-3), picture 1, and the attached instructions for use.
At Nationwide Children’s Hospital, if initiating ECMO via multiple cannulation sites, it will be our practice to drain from
one or both groins via the venous line, and to return the blood via the arterial line to the neck/right atrium cannulae. For
proper neck/groin cannulae please see NCH ECMO protocol Arterial Cannulae or Venous Cannulae.
127
Picture 1 – Shows proper cannulae position with the return ports directed toward the tricuspid valve.
128
Graph 1
12Fr VV Cannulae - Patient weight 2-5Kg
Select a cannulae that will provide full flow at a pressure loss of 20mmHg or less.
Graph 2
15Fr VV Cannulae - Patient Weight 4-8kg
129
Graph 3
18Fr VV Cannulae - Patient Weight 7-12Kg
130
131
132
133
134
Avalon VV cannulae
T
he Bi-Caval Dual Lumen Catheter is the world's first percutaneous, single site, kink resistant, veno-venous device
designed to enable optimal extracorporeal life support.
The
Advantage
Inserted into the Internal Jugular Vein this patent pending device is able to match the body's natural flow ratios by
simultaneously removing blood from both the SVC and IVC and returning blood to the Right Atrium.
Tapered Outer Diameter
Radiopaque to assist in catheter insertion and placement
135
Size
Lead Diameter
13 Fr. (4.3 mm)
11 Fr. (3.7 mm)
16 Fr. (5.3 mm)
14 Fr. (4.7 mm)
19 Fr. (6.3 mm)
16 Fr. (5.3 mm)
20 Fr. (6.7 mm)
17 Fr. (5.7 mm)
23 Fr. (7.7 mm)
20 Fr. (6.7 mm)
27 Fr. (9.0 mm)
24 Fr. (8.0 mm)
31 Fr. (10.3 mm)
27 Fr. (9.0 mm)
136
137
138
139
140
141
Product Specifications
Hemochron™ Response
Activated clotting time (ACT) is a whole blood test to determine clot formation over time (seconds) with the use of
heparin anticoagulation. An activator (glass beads) is present in the Tube. 0.4mL of fresh whole blood is utilized.
142
Circulatory Technology Inc. - Better Bladder™ and Bigger Better Bladder™
Specifications: Sterile 1/4” Better Bladder™ (BB14) 20mL
Sterile 3/8” Better Bladder™ (BBB38) 115mL
143
144
Terumo CDI 500™ in-line blood gas monitor
•
•
Measurement types
–
Optical fluorescence
–
Optical reflectance
ABG/VBG
–
pH 6.8-8.0
–
pCO2 10-80mmHg
–
pO2 10-500mmHg
•
SaO2/SvO2 60-100mmHg
•
K+ (1.0-8.0)
•
Hgb/Hct 5-15g/dl and 15-45%
•
Temp A/V 10-45C
•
pH/alpha stat blood gas management
•
45” @ full battery charge
•
8 hrs to recharge to full
Arterial cell
Venous cell
Views
Numeric
Graphic
145
Heater- Cincinnati Sub Zero
Patient Safeties
Three high temperature safety levels continuously monitor the water
temperature. In addition, once temperature setpoint is attained, if the
actual water temperature varies by more than 1°C from the setpoint,
the over/under setpoint alarm alerts the operator. Audible and visual
alarms and the automatic power shutdown add to the system's unique
protective design.
Warning: If the power supply to the CSZ ECMO heater is interrupted,
when power is returned, the heater will default to 37° Celsius.
Product Specifications
Water Temperature
20°C - 41°C (68°F - 105.8°F)
Flow Rate
78GPH
9in X 15in X 15.5in
Size
(23 cm x 38.1 cm x 39.4 cm)
Weight
28 lbs. (12.6 kg)
146
147
148
149
Maquet Quadrox iD & D® oxygenator
Quadrox iD
Quadrox D
0.2-2.8 l/min
0.5 – 7 l/min
Blood Flow Range
5.6 l/min
15 l/min
Max. Gas Flow
81ml
250 ml
Prime Volume
Diffusion
Polymethylpentene
Diffusion
Polymethylpentene
Bioline (Heparin)
Safeline (Albumin)
Surface Coating
Self venting hydrophobic
port
Self venting
hydrophobic port
Unique air handling
capabilities
0.8m2
1.8m2
Surface Area
Polyurethane
Polyurethane
Heat Exchanger
0.15m2
0.6 m2
HX Surface Area
95mmHg @2.8l/min
70 mmHg @7l/min
Pressure Drop @ max.
Quadrox D
Gas Membrane
Quadrox iD
150
VS
Thromboelastography (TEG®)
The Haemoscope TEG® analyzer measures the mechanical properties of the developing clot:
The time until initial fibrin formation.
The kinetics of the initial fibrin clot to reach maximum strength.
The ultimate strength and stability of the fibrin clot and therefore its ability to do the work of hemostasis
Clot dynamics
The resultant hemostasis profile can be evaluated and individual points in the profile indicate specific parameters of
patient hemostasis:
151
R
R Time is the period of time of latency from the time that the blood was placed in the
TEG® analyzer until the initial fibrin formation.
K
K Time is a measure of the speed to reach a certain level of clot strength.
α
α measures the rapidity of fibrin build-up and cross-linking (clot strengthening).
MA
MA, or maximum amplitude, is a direct function of the maximum dynamic properties
of fibrin and platelet bonding via GPIIb/IIIa and represents the ultimate strength of
the fibrin clot.
LY30 LY30 measures the rate of amplitude reduction 30 minutes after MA.
Modified Blood Samples
Native whole blood samples provide the most sensitive method for analysis. However, most times it is not practical or
necessary to run a straight native sample. For instance, samples can be citrated to prolong storage time. A wealth of
additional information can be obtained by running blood samples that have been modified before application on the
analyzer. For example:
Measure heparin effect using heparinase cups and pins
Speed analysis by adding kaolin or other activators
Test functional fibrinogen level by adding tissue factor and ReoPro
Test in vitro for the effect of any drug on a patient by adding it to the sample in a similar concentration.
The TEG® tracing can be a qualitatively or quantitatively analyzed. The patterns are easily interpreted without
measurement to determine conditions of hyper-, hypo-, normal coagulation, and fibrinolysis. However, by using the
measurements and established normal ranges and indices, the patterns can be quantified as to the degree of
abnormality, as described in Chapter 2 of the TEG® manual. This allows therapies to be judged for their effectiveness in
correcting a pathological state.
152
Tracings:
153
from Hemoscope TEG® User Manual regarding Adult treatment algorithm.
Transonic™ Flowmeter
Purpose: To accurately quantify blood flow irrespective of shunts, occlusion or resistance.
154
HT-100 model
Tubing
Size (internal diameter):
1/4”
3/8”
1/2”
Stroke volume (1ft.)
13mL
27mL
45mL
Wall Thickness:
1/16”
3/32”
155
Flow rates:
Arterial
1/4”
3/8”
Maximum
3L/min
6L/min
Venous
1/4”
3/8”
1/2”
Maximum
1.3L/min
4L/min
6L/min
Coatings:
Maquet Safeline®
Is a bioinert surface treatment consisting of synthetic immobilized albumin.
Medtronic Carmeda®
156
Ultrafiltration- Terumo HC05S™
Specifications:
35 mL prime volume
Maximum fluid removal (see chart below)
100 – 500mL/ minute blood flow rate
50mL/minute minimum recommended blood flow rate
Maximum transmembrane pressure 500mmHg
157
Appendix
Cardiac ECMO Activation Sequence
CICU:
Date notified:_________________
CICU attending physician contacts the CV surgeon on call.
Time notified:_________________
If decision is made to place patient on ECMO
CICU attending physician:
Obtains guardian/patient consent.
Instruct Charge Nurse to contact the Operating Room front desk (24100) and the hospital operator.
Charge Nurse:
Call the OR front desk (24100):
Time notified:________________
Inform them that the patient in bed space __ is going to be placed on cardiac ECMO, the patient’s
weight is__.
Ask OR to call perfusionist AND cardiac nurses on call.
Ask OR nurse to bring cardiac ECMO cart, headlight, room 1 bovie, surgeon loupes and CV travel box
to CICU bed space __.
Call blood bank (25391):
Time notified:________________
Provide them with your name and title, and the patients name and MRN. Inform them blood
products 3-4 units PRBC’s and 1-2 units FFP are needed for cardiac ECMO.
Call Hospital Operator (0):
Time notified:________________
Give the hospital operator the following information; unit, bed space, cardiac ECMO and weight. The
hospital operator will then activate the ECMO team pagers.
Resident/Fellow or Advance Practice Nurse:
Activate Cardiac ECMO pre-ECMO lab order set:
CBC w/diff, PT, aPTT, Fibrinogen, AST, ALT, LDH, BUN, Creatinine, Electrolytes, Glucose, Lactate,
Plasma Free Hgb, Total Protein, Albumin, Alk Phosphate, iCa++, PKU, D-Dimer, Total bilirubin,
GGTP, Uric Acid, Neonatal workup for patients < 4 months, > 4 months type and screen.
Activate Cardiac ECMO cannulation order set.
Consider cardiac ECHO.
Consider head ultrasound (HUS).
158
ECMO Specialist Shift Report Form
ECMO Specialist Shift Report
Patient Name:___________________________
On ECMO Date/Time:
Cannula: Art:________ Ven:_______ Ven:_____
Dry wt:________Kg, Allergies:______________
Dx:_____________________________________
Problems:______________________________
______________________________________
_______________________________________
Pertinent Hx:____________________________
_____________________________________
Plan:___________________________________
______________________________________
Precautions/Pitfalls:______________________
_____________________________________
Vent settings_____________________________
Pump flow_____________LPM __________RPM
Sweep gas: flow______LPM, Blender______%
Carbogen flow________LPM_________PSI
Carboair flow________LPM_________PSI
Pump pressure ranges:
Bladder____________________mmHg
Pre-membrane______________mmHg
Post-oxygenator_____________mmHg
Δ P ____________ mmHg
Actual ranges:SaO2________%, SvO2_______%
ACT goal______-______ Actual_______-_______
Total IV rate______ml/hr or _________ml/kg/day
Heparin rate________ml/hr or ______u/kg/hr
gtts to circuit__________________________
_____________________________________
gtts to patient__________________________
_____________________________________
_____________________________________
Urine out:__________ml ___________ml/kg/hr
Hemofilter order: _________________________
Ultrafilter (off)____________________ ml/hr
Dialysate (in)_____________________ml/hr
Filter blood products? Yes : No
Amount & type of blood products given:
PRBC_________________ml or units
FFP___________________ml or units
Platelets_______________ml or units
Cryo__________________ml
Other__________________ml
PHONE #s
Lab……………………….25350
Blood Bank………....….25391
Goals
MAP > ______________________________
H/H_________________________________
Platelets ____________________________
PTT ________________________________
Xa (actual)_______________________ u/ml
ATIII ________________________________
Circuit:
_________________________________________
_________________________________________
_________________________________________
_________________________________________
Notes:
_________________________________________
_________________________________________
_________________________________________
_________________________________________
_________________________________________
_________________________________________
_________________________________________
_________________________________________
_________________________________________
I & O RECORD:
Balance from last shift______________________
Lab
out
Product given/amount
New
balance
Pharmacy…...22153 Satelite…...22170
Sleep rooms……Neo 88577 ….....…Ped 26354
Attending Office….Neo 24658/24742
\shared\Perfusion Shared\ecmo\2010\protocol\shiftrpt.xls (01/10)
159
ELSO Center Guidelines
ELSO GUIDELINES FOR ECMO CENTERS
Purpose
These guidelines developed by the Extracorporeal Life Support Organization, outline the ideal institutional
requirements needed for effective use of extracorporeal membrane oxygenation (ECMO). The Extracorporeal
Life Support Organization recognizes that differences in regional and institutional regulations especially
concerning hospital policies may result in variations from these guidelines. These guidelines will be reviewed
and updated every three years in an attempt to keep the document current.
Information and Background
Extracorporeal Membrane Oxygenation (ECMO) was first used successfully for neonates with respiratory failure
in 1975. Today it is an accepted treatment modality for neonatal, pediatric and adult patients with respiratory
and/or cardiac failure failing to respond to maximal medical therapy.
ECMO is defined as the use of a cardiopulmonary bypass circuit for temporary life support for patients with
potentially reversible cardiac and/or respiratory failure. ECMO provides a mechanism for gas exchange as well
as cardiac support thereby allowing for recovery from existing lung and/or cardiac disease.
It has been estimated that approximately 2800 newborns could benefit could benefit from ECMO annually in the
US (one of every 1309 live births). Pediatric and adult patients are being successfully treated in increasing
numbers.
General
1. ECMO centers should be located in tertiary centers with a tertiary level Neonatal Intensive Care Unit,
Pediatric Intensive Care Unit and/or Adult Intensive Care Unit.
2. ECMO Centers should be located in geographic areas that can support a minimum of 6 ECMO patients per
center per year. The cost effectiveness of providing fewer than 6 cases per year combined with the loss, or
lack of clinical expertise associated with treating fewer than this number of patients per year should be
taken into account when developing a new program.
3. ECMO Centers should be actively involved in the Extracorporeal Life Support Organization (ELSO) including
participation in the Central Registry.
NIH, "Report of the Workshop on Diffusion of ECMO Technology", 1990
Organization
A. General Structure: The ECMO center should be located in a tertiary level intensive care unit with the
following components.
1. There should be a physician ECMO program director with responsibility for the overall operation of the
center.
2. There should be an ECMO coordinator with responsibility for the supervision and training of the technical
staff, maintenance of equipment, and collection of patient data.
3. The multi-disciplinary ECMO Team should have quality assurance review procedures in place for annual
ECMO evaluation internally.
4. Formal Policy and Procedures outlining the indications and contraindications for ECMO, clinical management
of the ECMO patient, maintenance of equipment, termination of ECMO therapy, and follow-up of the ECMO
patient should be available for review.
5. Appropriate laboratory space for training and continuing medical education should be available.
B. Staffing Issues
160
1. The ECMO staff should meet the requirements of their subspecialty training as set forth by their specific
governing board (American Board of Surgery, American Board of Pediatrics, etc.). In addition, ECMO staff
should meet the training requirements described below.
2. The medical director should be either a board certified neonatologist, a board certified critical-care
specialist, or a board certified pediatric, cardiovascular, or thoracic surgeon.
3. The ECMO coordinator may be an experienced neonatal, pediatric, or adult intensive care registered nurse
or registered respiratory therapist with a strong ICU background (minimum of 1 year of ICU experience), or a
certified clinical perfusionist with ECMO experience.
4. An ECMO-trained physician will provide 24-hour on-call coverage for the ECMO patient. The physician may
be a neonatologist, pediatric or adult critical-care specialist, a neonatology or critical care fellow, or other
physician who has completed at least three years of post-graduate pediatric, surgical, or adult medical
training and has specific ECMO training.
5. There shall be an ECMO clinical specialist as described below to provide 1:1 or 1:2 care throughout the
course of ECMO.
6. The ECMO Specialist should have a strong intensive care background (1 year of NICU or PICU experience
preferred) and have attained one of the following:
(1) Successful completion of an approved school of nursing and achievement of a passing score on the state
written exam given by the Board of Nursing for that state;
OR
(2) Successful completion of an accredited school of respiratory therapy and have successfully completed
the registry examination for advanced level practitioners and be recognized as a Registered Respiratory
Therapist (RRT) by the National Board of Respiratory Care (NBRC).
OR
(3) Successful completion of an accredited school of perfusion and national certification through the
American Board of Cardiovascular Perfusion (ABCP).
OR
(4) Physicians trained in ECMO who have successfully completed institutional training requirements for the
clinical specialists.
7. In addition to #5, it is recommended that a bedside pediatric or NICU nurse provide 1:1 or 1:2, care
throughout the course of ECMO.
8. Additional support personnel from the permanent hospital staff should be available on a 24 hour/day on-call
basis:
(1) Physicians or other medical personnel who routinely care for neonates from the following disciplines:
Pediatric/adult cardiology
Pediatric/adult cardiovascular surgery
Pediatric/general surgery
Cardiovascular perfusion
Pediatric/adult anesthesiology
Pediatric/adult neurosurgery
Pediatric/general radiology
Genetics
(2) Biomedical engineer
(3) Respiratory therapists experienced in intensive care
9. The following consultants should be available as needed.
• Pediatric/adult neurology
• Pediatric/adult nephrology
161
•
•
Occupational/physical therapist
Developmental/rehabilitation specialist
10. A fully trained and equipped transport team should be available 24 hours a day.
11. Trained individuals capable of providing development follow-up or rehabilitation should be available and
capable of providing long-term follow-up to the ECMO patient.
C. Physical Facilities and Equipment
1. If the space allocated for ECMO is located outside the ICU, it should be in close proximity to and have
appropriate communication with the ICU to assure additional staff support for any emergency that may
arise.
2. An ECMO system consists of a suitable blood pump, a system for servo- regulation to balance venous
drainage rate from the patient and blood return to the patient, an appropriate blood heat exchanger and
warming unit, appropriate disposable materials including membrane oxygenator tubing packs, and
connectors, all suitable for prolonged extracorporeal support.
3. A device for monitoring the level of anticoagulation (ACT or other) with appropriate supplies should be at
the bedside.
4. The following equipment should be readily available:
• Backup components of the ECMO system and supplies for all circuit components.
• Adequate lighting to support surgical interventions.
• Surgical instrument set for revision of cannulae or exploration for bleeding complications.
5. The following support facilities with staff should be available on a 24-hour basis.
A blood gas laboratory
Laboratory for blood chemistry and hematologic testing
Blood bank
Radiographic support including cranial ultrasound and CATscan
Cardiovascular operating room facilities with cardiopulmonary bypass capabilities located within the
hospital doing ECMO and available 24 hours a day.
D. Staff Training and Continuing Education
1. Each ECMO center should have a well-defined program for staff training, certification, and re-certification.
This program should include: didactic lectures, laboratory training with the ECMO equipment, bedside
training, and a defined system for testing proficiency of the team members (See ELSO Guidelines for Training
and Continuing Education of ECMO Specialists)
2. Each member of the ECMO team should successfully complete this program.
3. A well-defined program of routine continuing education and emergency training for ECMO staff should be
outlined with records documenting participation by active team members.
4. It is recommended that team members not involved in ECMO pump management for > 3 months should be
required to go through a re-certification process as defined by the ECMO program.
E. Selection Criteria
1. ECMO is indicated for selected neonatal, pediatric and adult patients with severe, acute cardiac and/or
respiratory failure who have failed to respond to conventional medical management.
2. Each ECMO center should develop institutional criteria for ECMO therapy, including indications and
contraindications.
3. It is recommended that the ECMO center develop guidelines for transfer of the ECMO patient.
162
F. Patient Follow-up
Each ECMO center should have a well-defined developmental follow-up program for the ECMO patient with
appropriate subspecialty support (refer to ELSO Guidelines for Follow-up).
G. Program Evaluation
1. A well-defined system should be instituted for assuring that formal meetings of key ECMO team members
occurs on a routine basis to review cases, equipment needs, administrative needs, and other pertinent
issues. Minutes to these meetings should be available for review.
2. A prompt review of any major complication or death should be held both with ECMO team members and
with the responsible Morbidity and Mortality committee in the hospital. These reviews should be
conducted under the relevant quality assurance laws for the state where the center is located.
3. Formal clinical-pathological case reviews with a multi-disciplinary approach should be regularly conducted
(as outlined by JCAHO regulations).
4. An Annual Data Report, utilizing the center's collated data, or the collated report of data submitted to the
ELSO Neonatal ECMO Registry, should be available for quality assurance review.
5. Records documenting maintenance of equipment should be kept (as per JCAHO regulations).
ELSO Guidelines for Training
ELSO GUIDELINES FOR TRAINING AND CONTINUING EDUCATION OF ECMO SPECIALISTS
PURPOSE
The "ELSO Guidelines for Training and Continuing Education of ECMO Specialists" is a document developed by the
Extracorporeal Life Support Organization (ELSO) as a reference for current and future ECMO centers. It is to be used as a
guideline for designing training and education programs for ECMO specialists. It is assumed that each ECMO center
must develop their institution specific guidelines and policies for training ECMO Specialists, which may vary. In the
development of these documents and programs, ECMO Directors and Coordinators must take into account their
institution's requirements for in-house training programs, and must have policies and procedures reviewed by
appropriate hospital committees. Please note that institutional and personnel requirements for ECMO programs are
addressed in the ELSO document, "Guidelines for ECMO Centers", and will not be discussed in this document.
INTRODUCTION
The term "ECMO Specialist" is defined for the purpose of these guidelines as "the technical specialist trained to manage
the ECMO system and the clinical needs of the patient on ECMO under the direction and supervision of a licensed ECMO
trained physician. The individual functioning as the ECMO Specialist should have a strong critical care background in
neonatal, pediatric and/or adult critical care and have attained one of the following:
[1]
Successful completion of an approved school of nursing and achievement of a passing score on the state written
exam given by the Board of Nursing for that state for registered nurses.
[2]
Successful completion of an accredited school of respiratory therapy (two - four years) and achievement of a
passing score on the Registry exam given by the National Board for Respiratory Care (NBRC).
[3]
Successful completion of an accredited school of perfusion and national certification through the American
Board of Cardiovascular Perfusion (ABCP) (licensure to practice as a clinical perfusionist (if license available) or (if not
available) authorized to practice as a clinical perfusionist in the hospital and state).
[4]
Licensed physician.
TRAINING
163
Training of ECMO will be divided into two parts. Training for new ECMO programs (centers which have not treated
patients) will be covered separately from training for experienced ECMO programs (centers which have been in ongoing
operation and are training new ECMO specialists).
TRAINING OUTLINE: NEW ECMO PROGRAM
A.
Didactic Course: The didactic course should include, but not be limited to the following topics. Between 24 to 36
hours will be required to cover the following material. Case presentations are encouraged.
Topics could include, but are not limited to the following:
Introduction to ECMO:
History,current status, indications,risks and benefits, membrane gas exchange physics and physiology, oxygen content,
delivery and consumption, shunt physiology, types of ECMO, future applications, research
Physiology of the diseases treated with ECMO:
Persistent Pulmonary Hypertension, Meconium Aspiration Syndrome, Respiratory Distress Syndrome, Congenital
Diaphragmatic Hernia, Sepsis/pneumonia, Post-operative congenital heart disease/heart, transplantation,
cardiomyopathy/myocarditis, ARDS, aspiration pneumonia, pulmonary embolism .
Pre ECMO Procedures:
Notification of the ECMO Team
At Nationwide Children’s Hospital for Cardiac ECMO, FIRST, contact the CV surgeon on call.
If decision is made to place patient on ECMO (see Cardiac activation under NCH ECMO
Initiation CICU guideline)
Cannulation procedure -open -percutaneous
Initiation of bypass
Responsibility of team members
•
Criteria and contraindications for ECMO including:
Patient Selection
Selection criteria Pre-ECMO evaluation
• Physiology of coagulation including: Coagulation cascade Activated clotting times (ACT's) Disseminated
intravascular coagulation Blood products and interactions Blood product management of the bleeding patient Blood
surface interactions Laboratory tests Heparin pharmacology Use of Amicar, Protamine and other drugs
• ECMO equipment including: Circuit priming Oxygenator function and blood gas control ECMO circuit design
ECMO circuit components (cannula, pump, venous return monitor, in-line saturation monitor, pressure monitor,
heater, hemofilter, bubble detector)
•
Physiology of Venoarterial and Venovenous ECMO: Indications Physiology Advantages/disadvantages
•
Daily Patient and Circuit management on ECMO including:
1.
2.
3.
4.
5.
6.
Fluid, electrolytes and nutrition
Respiratory
Neurologic
Infection control
Sedation and pain control
Hematology
164
7. Cardiac
8. Psychosocial
9. Circuit:
a. Aseptic technique
b. Pump/gas flow
c. Pressure monitoring
d. Blood product infusion techniques
e. Circuit infusions
f. Management of anticoagulation
g. Circuit checks
h. Hemofiltrations set-up
i. Bedside care of the ECMO patient
• Emergencies and complications during ECMO:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Intracranial and other hemorrhage
Pneumothorax/pneumopericardium
Cardiac Arrest
Hypotension/hypovolemia
Severe coagulopathy
Seizures
Hemothorax/hemopericardium
Uncontrolled bleeding
Mechanical:
a. Circuit disruption
b. Raceway rupture
c. System or component alarm/failure (pump, bladder, venous return monitor,
oxygenator, heater)
d. Air embolus
e. Inadvertent decannulation
f. Clots
• Management of complex ECMO cases: Surgery on ECMO
-post-operative bleeding Transport on ECMO (inter and intra-hospital)
• Weaning from ECMO (techniques and complications):
Clinical indications of pulmonary/cardiac recovery Pump/gas flow weaning techniques ACT changes during weaning
Ventilatory changes during weaning Trial off/decannulation from low flow
• Decannulation procedures: Personnel needed Medications required Potential complications Vessel ligation
Vessel reconstruction Percutaneous approach
•
Post ECMO complications: Platelet and electrolyte alterations
• Short and long-term developmental outcome of ECMO patients: Institutional follow-up protocol Literature
review
Ethical and social issues:
Consent process
Parental and family support
165
Withdrawal of ECMO support
B.
Water-drills: These sessions should be small enough so that each individual has hands-on experience. A full
understanding of all possible circuit emergencies and the appropriate intervention should be accomplished by the end of
this session. Each trainee should be able to describe and conceptually demonstrate how to change the major equipment
(oxygenator, heat exchange, bladder) in a reasonable period of time. They should be able to change less complicated
components of the circuit (raceway, pigtails, and checking pump head occlusion on ECMO) in a pre-established period of
time.
•
Basic Session should include a discussion and demonstration of the equipment including: Review of Circuit
configuration and function Access and sample ports to the circuit “The basic circuit check’ Basic troubleshooting
Pigtail and stopcock changes
•
Emergency Session, should include training in the management of:
Raceway ruptures, heat exchanger, bladder, membrane lung changes (assist with procedure only),
Venous/arterial air, Pump head occlusion checks, power failure,
Inadvertent decannulation.
C.
Animal Laboratory Sessions: As bedside training sessions are not possible in a new ECMO center, more
extensive laboratory training is required compared to an experienced center.
• The species of animal and the duration of the ECMO training run will vary depending on the institution's ability
to supply long-term support of animals during these sessions. ECMO centers typically have used newborn
lambs, adult sheep or piglets. It is recommended that animal labs be conducted for a continuing 24-72 hour
period to decrease the number of animals needed for these sessions and to simulate around the clock
management of the ECMO system.
• Trainees should be divided into small teams with the instructor for four to eight hour sessions.
• Sessions should include a review of the circuit and the access and sampling ports and the trainees should
practice such tasks such as blood product administration, IV solution administration, medication administration
and blood gas, ACT, and laboratory sampling. The use of documentation such as the flowsheet, physician and
standing orders should be incorporated used during this session.
• Each specialist should be able to manage the patient on ECMO while the parameters (ACT, PaO2, and Post
PCO2) are altered. It is recommended that this session should last 8-12 hours.
• A session, lasting 4-8 hours, should focus on emergencies including: Cracked pigtails and connectors Leaking
stopcocks Raceway rupture Membrane oxygenator failure Air in the circuit Loss of venous return Inadvertent
decannulation Pump stop scenarios and handcranking Power failure
• For new centers these sessions should be repeated until all team members gain a solid understanding of the
management of the ECMO system and are fully competent managing simulated ECMO emergencies. After
initial sessions, most centers require one - two additional eight-hour sessions per specialist.
EXPERIENCED CENTER: TRAINING OUTLINE
A.
Didactic Sessions - as above
B.
Water-drills - as above
C.
Animal Sessions: Time in the animal lab is not required for experienced centers, but may be useful. If animals
are not used, additional water drill time can be added.
D.
Bedside Training: The bedside training time of the new Specialist should be between 16 and 32 hours in 8 or 12hour shifts. The preceptor should be an experienced specialist.
166
EVALUATION AND INSTITUTIONAL CERTIFICATION OF THE ECMO SPECIALISTS
A.
Written Evaluation: Each specialist should have on record a written evaluation of their skills and competence
during all sessions of the ECMO training course including; course attendance, water-drills, animal lab sessions and
examinations.
B.
Written/Oral Exam: Written exam, with pre-determined passing level, covering didactic and laboratory sessions
should be taken by all Specialists.
C.
Institutional Certification: Institutional certification of Specialists will be granted after successful completion of
the ECMO training course (didactic, water drills/animal labs, bedside training) and successfully passing the oral and/or
written exam.
CONTINUING EDUCATION OF THE ECMO SPECIALIST
A.
Formal team meetings, which include: Case reviews Updates on ECMO therapy Quality assurance Review of
ECMO policy and procedures Administrative information
• Frequency of meetings should be based on the size of the team and the volume of ECMO patients treated.
• Attendance records should be monitored and team members should be required to attend a certain number of
meetings as specified by the particular ECMO center.
B.
Water-drills: Water drills should be held periodically throughout the year as specified by the particular ECMO
center (every six months is recommended as a minimum). The exact interval should be based on volume of ECMO
patients treated in the ECMO center.
C.
Annual examination: This is recommended to verify the knowledge and skills of all specialists. Ongoing
evaluation of performance should also be conducted and reviewed with the Specialist.
D.
Minimum number of hours of pump time: Each center should set a minimum amount of pump time for the
specialist to maintain competency. For example, a center might specify that each Specialist performs at least one 8-hour
clinical shift every eight weeks in order to maintain certification. Re-training should be undertaken if this standard is not
met.
DOCUMENT SUMMARY
Final, 12-92 Reviewed 01-97, approved with no changes Reviewed 10-99, with changes Reviewed, 10-99, 9-04,
Approved with changes, 2-05
ELSO Guidelines for Neonatal ECMO Centers (via ELSO website)
PURPOSE
The ELSO Guidelines for Neonatal ECMO Consultation is a document developed by the Extracorporeal Life Support
Organization (ELSO) as a reference for physicians considering the transfer of critically ill neonates to a critical care unit
with neonatal ECMO capability.
INFORMATION AND BACKGROUND
Extracorporeal Membrane Oxygenation (ECMO) is presently being used for term or near-term infants who are at high
risk of dying from respiratory failure. Since it is not feasible for all neonatal intensive care units within a particular
region to provide ECMO, the timeliness of the transfer of a critically ill neonate from a regional NICU to an ECMO center
becomes an important consideration in the prudent clinical management of the patient. This document can suggest
consideration for transfer of the potential ECMO patient, but because data to develop specific criteria are not available,
there are no universally accepted guidelines. Early consultation with an ECMO center and continued communication
between the center and the referring physician will facilitate the determination for the appropriate time for transfer. A
167
review of representative criteria used for ECMO and typical ventilator settings and blood gas data for a potential
candidate prior to ECMO will be presented and used to define reasonable guidelines for transfer.
GENERAL INCLUSION/EXCLUSION CRITERIA FOR ECMO
There are several important "inclusion" and "exclusion" criteria for ECMO based on known benefits and complications of
the procedure. These are listed in Table 1 and discussed below. Each ECMO Center may have a slightly different
approach to these criteria which will be determined by consultation with that center.
1.
Gestational age > 34 weeks and Birth Weight > 2000 Grams
The requirement for systemic heparinization of the ECMO patient places significant limitations on the population
treated. In the late 1960's and early 1970's ECMO was used for premature infants who weighed less 2000 grams or were
less than 34 weeks gestation. This resulted in a significant mortality and morbidity from intracranial hemorrhage.
Although refinement of the procedure occurred in the early 1980's, the premature infant continued have a significant
risk of intracranial hemorrhage with ECMO therapy. This increased risk may be a result of the combination of systemic
heparinization and altered cerebral circulation as a result of ECMO, or it may be due to primary disease entity causing
cerebral ischemia in a susceptible infant. ECMO therapy, including heparin management, has been further refined in the
1990's. Although most ECMO centers will not treat the premature infant <34 weeks gestation, some centers are
cautiously studying this population to see if they can be considered as ECMO candidates. Better understanding of
effects of ECMO perfusion on the brain, in addition to new technical advances such as heparin-bonded circuits, may
permit lowering the gestational age cutoff in the future. However, at the present time ECMO therapy is not
recommended for infants <34 weeks gestation. Although 2000 grams is generally considered a minimum birth weight,
small for gestational age infants > 34 weeks gestation should not be excluded based on weight only.
2.
Lack of Significant Coagulopathy or Bleeding Complications
The requirement for systemic heparinization also places the infant with a significant coagulopathy or pre-existing
bleeding complications, such as pulmonary hemorrhage, at extreme risk. All attempts should be made to correct any
coagulopathy prior to the institution of ECMO. Severe coagulopathy which cannot be controlled or corrected with
appropriate blood product replacement may be a relative contraindication for ECMO. Consultation with the ECMO
center physician will help determine which infants should be excluded because of bleeding problems.
The septic infant is of concern because of the commonly associated of coagulopathy. Although these infants are at a
higher risk for bleeding complications on ECMO, treatment of their coagulopathy and meticulous heparin management
have allowed these infants to be successfully treated. Early consultation is important for this group of infants because
they can deteriorate quickly making transfer difficult.
Many infants who have blood-tinged tracheal aspirate fluid before ECMO can be managed on bypass with higher peak
end expiratory pressures (PEEP) and modified heparin administration. The infant with an uncontrolled, massive
pulmonary hemorrhage prior to ECMO should generally not be considered a candidate. Almost all deaths on ECMO are
related to a bleeding complication. Consultation with an ECMO center is the best way to determine if a given patient's
coagulation defect would contraindicate treatment.
3.
No Major Intracranial Hemorrhage
The need for heparin therapy also precludes the treatment of infants with major intracranial hemorrhage. An infant
with a Grade I intraventricular hemorrhage (IVH) or a small parenchymal hemorrhage can be treated with lower heparin
therapy and close monitoring of activated clotting times. Centers may vary on the definition of Grade I vs. Grade II IVH.
Consultation with your ECMO center is suggested before an infant is denied ECMO because of pre-existing IVH.
4.
Mechanical Ventilation Less than 10-14 Days and Reversible Lung Disease
More than 10-14 days of assisted ventilation prior to ECMO is a relative contraindication to the procedure. It is known
that lung fibrosis and/or chronic lung changes occurs with prolonged mechanical ventilation and exposure high oxygen
concentrations. The exact timing of these changes vary per child, thus clinical considerations must determine when the
lung disease is no longer reversible in a relative short period. Chronic lung injury cannot improve or completely reverse
168
within the time period that ECMO can be used safely. Although the length of time an infant can safely remain on the
ECMO circuit not known, most centers limit the duration of ECMO to less than 30 days because of the increased risk of
complications after approximately 14 days of therapy. Chronic lung diseases which do not improve in a short time
period should not be treated with ECMO unless there is a superimposed, life-threatening acute disease state such as
pulmonary hypertension which can be reversed by ECMO. Early consultation allows time for the referring and ECMO
physicians to judge progression of the disease and possibly intervene before irreversible lung injury occurs.
5.
No Uncorrectable Cardiac Lesions
An important component of the pre-ECMO evaluation is an echocardiogram to rule out 1) inoperable cardiac diseases, 2)
anomalies in which ECMO support provides little benefit, or 3) operable cardiac lesions without significant lung disease
which require surgical treatment, not ECMO. Select infants with congenital heart disease may be candidates for ECMO
pre-repair of their cardiac anomaly. ECMO may stabilize a patient and allow proper studies, even cardiac
catheterization. ECMO may also be used to treat associated lung disease and make neonates better candidates for
surgery.
6.
No Lethal Congenital Anomalies
ECMO centers may vary in their definition of congenital anomalies which incompatible with life and, therefore,
contraindicate the use of ECMO. When an infant is born with an unusual, potentially lethal anomaly, early discussions
between referring and ECMO physicians may help to define the appropriateness of ECMO therapy.
7.
No Evidence of Irreversible Brain Damage
Irreversible brain damage can be difficult to determine. Consultation with the ECMO center physician can assist in this
determination.
HIGH MORTALITY RESPIRATORY CRITERIA
The statement "after maximal medical therapy" has many caveats, but once an infant is failing conventional therapy for
respiratory insufficiency, ECMO should be considered. Based on retrospective data from their own institutions, most
ECMO centers utilize specific criteria which attempt to predict a high percent mortality without ECMO. Because these
criteria assume the use of therapeutic techniques which may be available only at the ECMO center, these criteria have
limited application at the referring hospital. In addition, infants allowed to meet ECMO criteria before transfer have an
increased risk of death because deterioration may result very rapidly once baseline ECMO criteria are met.
Commonly used criteria are the 1) Alveolar-arterial (A-a) oxygen gradient over a specific time period, 2) Oxygen index
(OI) over a specific time period, and 3) PaO2 levels less than 50 mm Hg over a limited time period. Table 2 lists
commonly used ECMO criteria. Infants are sometimes placed on ECMO using the criterion of "acute deterioration." In
most centers this means placing on ECMO an infant who is in impending or full cardiopulmonary arrest. This includes
patients who have PaO2's less than 30 mm Hg with or without hypotension.
1)
AaDO2 = P - 47 - PaCO2 - PaO2
where P is the barometric pressure and 47 is the pressure of water vapor, when FIO2 is 1.00
2)
0I = MAP x FIO2 x 100
PaO2
where MAP is the mean airway pressure
ECMO REFERRALS: WHEN TO CALL AND HOW TO TRANSPORT
One of the most difficult tasks for a referring physician and a consulting ECMO physician is to determine when a patient
needs to be transferred to an ECMO center. The majority of infants with disease states frequently treated by ECMO
improve without ECMO and, therefore, referral may not be necessary. The decision to transfer is an enormous
responsibility which can be eased by early consultation with the ECMO center thereby allowing both teams to decide
when to move a patient. However, when an infant is at high risk for failing maximal therapy the referring physician
should decide to transfer before the patient is too moribund for safe transport.
169
The progression of respiratory insufficiency due to pulmonary hypertension is not linear. Deteriorating oxygenation will
respond to increasing ventilatory parameters to a certain point; once this is exceeded (approximating ECMO criteria)
there may be rapid progression to a refractory hypoxic cardiac arrest. To decrease the risk of death prior to transport,
infants should be transferred prior to meeting ECMO criteria. Kanto, and associates, found that 12 percent of their
ECMO referrals died prior to the transport team's arrival or during transport. Of these deaths, 32 percent were patients
with congenital diaphragmatic hernias, thus indicating that early referral of these patients is especially warranted. High
frequency ventilation, both jet and oscillatory ventilation, are being used more frequently in this population of infants.
Referral of infants on high frequency oscillatory ventilation should be at a time when they can be converted to
conventional ventilation for transfer, for in most cases, infants cannot be transported on the oscillator. Most centers
agree that if the infant has not improved on the oscillator after 6 hours of oscillation, that referral to an ECMO center
should be considered.
There are no standard criteria for transfer. As can be seen in Table 3, immediately prior to the institution of ECMO the
typical patient is being ventilated at 96 breaths per minute (BPM) with a peak inspiratory pressure (PIP) of 45.9 cmH20
and FIO2 of 1.00. Average arterial blood gases include a pH 7.39, PaCO2 41, and PaO2 41 torr. Consultation for transfer
should occur before these ventilator settings are necessary and prior to a PaO2 of 40. As noted in Table 3, a respiratory
acidosis resulted in a significant increase in mortality. An infant who cannot be adequately ventilated despite maximal
mechanical support is a candidate for expedient transfer.
ECMO CONSULTATION
The referring physician should begin to consider the need for ECMO when a patient who has received appropriate
medical management has a Pa02 of 50-60 mm Hg when the PIP is >35 cmH20 and the FI02 is 1.00 for conventional
ventilation, and after 6 hours of high frequency ventilation without improvement in oxygenation. After consultation
with an ECMO physician the time of transfer can be determined through a team approach taking into account such
items as transport time, type of transport needed, and regional availability of "ECMO beds.""
Studies recommended prior to transfer for ECMO
Cardiac evaluation by ultrasound (if available at your institution) should be performed to identify uncorrectable heart
disease that would contraindicate the use of ECMO. Other diagnostic studies which should be obtained prior to transfer
of the ECMO candidate include: 1) head ultrasound (within 24 hours) to rule out a significant intracranial hemorrhage; 2)
tests of coagulation status including a partial thromboplastin time (PTT), prothrombin time (PT), fibrinogen, fibrin
degradation products (FDP), and platelet count; 3) calcium and electrolyte levels; 4) white blood cell count with
differential; 5) hemoglobin and hematocrit levels and 6) blood type and cross. These baseline studies will provide
additional information to the ECMO consultant and help to define possible difficulties.
TRANSPORT OF THE ECMO CANDIDATE
Early consultation with the ECMO center will allow for the logistics of transport to be completed in a timely fashion. At
the time of the initial consultation the referring center and the ECMO physician should determine a contingency plan for
transport. The distance between hospitals, the availability of the ECMO bed, and the stability of the patient will be
important factors in determining which team will transport and what type of transport vehicle will be used.
IN SUMMARY: Early consultation with an ECMO center is encouraged and should result in appropriate and safe transfer
of the potential candidate prior to the infant's actually meeting criteria for the institution of ECMO therapy.
REFERENCES
Major Text Book: Extracorporeal Life Support, Eds: Arensman RM and Cornish JD, Blackwell Scientific Publications,
Cambridge MA, 1993.
Bartlett RH, Roloff DW, Cornell RG, et al: Extracorporeal circulation in neonatal respiratory failure: A prospective
randomized trial. Pediatrics 1985; 76(4):479-487.
170
Beck R, Anderson KD, Pearson GD, et al: Criteria for extracorporeal membrane oxygenation in a population of infants
with persistent pulmonary hypertension of the newborn. J Pediatr Surg 1986; 21(4):297-302.
Boedy RF, Howell CG, Kanto WP: Hidden mortality rate associated with extracorporeal membrane oxygenation. J
Pediatr 1990; 117:462-464.
Callaghan JC, delos Angeles J: Longterm extracorporeal circulation in the development of an artificial placenta for
prematurity and respiratory distress syndrome. Surg Forum 1961; 12:215-217.
Cilley RE, Zwischenberger JB, Andrews AF, et al: Intracranial hemorrhage during extracorporeal membrane oxygenation
in neonates. Pediatrics 1986; 78:699-703.
Cole CH, Jillson E, Kessler D: ECMO: Regional evaluation of need and applicability of selection criteria. AJDC 1988;
142:1320-1324.
Day SE, Chapman RA: Transport of critically ill patients in need of extracorporeal life support. Crit Care Clin 1992;
8(3):581-596.
Dorson WJ, Baker E, Cohen ML, et al: A perfusion system for infants. Trans Am Soc Artif Intern Organs 1969; 15:155.
Dworetz AR, Moya FR, Sabo B, Gladstone I, Gross I: Survival of infants with persistent pulmonary hypertension without
extracorporeal membrane oxygenation. Pediatrics 1989; 84(1):1-6.
Heaton JFG, Redmond CR, Graves ED, Falterman KW, Arensman RM: Congenital diaphragmatic hernia. Improving
survival with extracorporeal membrane oxygenation. Pediatr Surg Int 1988; 3:6-10.
Howell CG, Hatley RM, Boedy FR, et al: Recent experience with diaphragmatic hernia and ECMO. Ann Surg 1990;
211(6):793-798.
Kanto WP: A decade of experience with neonatal extracorporeal membrane oxygenation. J Pediatr 1994;124:335-347.
Krummel TM, Greenfield LJ, Kirkpatrick BV, et al: Alveolar-arterial oxygen gradients versus the neonatal pulmonary
insufficiency index for prediction of mortality in ECMO candidates. J Pediatr Surg 1984; 19(4):380-384.
Langham MR, Krummel TM, Bartlett RH, et al: Mortality with extracorporeal membrane oxygenation following repair of
congenital diaphragmatic hernia in 93 infants. J Pediatr Surg 1987; 22(12):1150-1154.
Marsh TD, Wilkerson SA, Cook LN: Extracorporeal membrane oxygenation selection criteria: Partial pressure of arterial
oxygen versus alveolar-arterial oxygen gradient. Pediatrics 1988; 82(2):162-166.
McCune S, Short BL, Miller MK, Lotze A, Anderson KA: Extracorporeal membrane oxygenation therapy in neonates with
septic shock. J Pediatr Surg 1990; 25(5):479-482.
Newman KD, Van Meurs KP, Short BL, Anderson KD: Extracorporeal membrane oxygenation and congenital
diaphragmatic hernia-should any infant be excluded? J Pediatr Surg 1990;25(10):1048-1052.
Report of the Workshop on Diffusion of ECMO Technology, National Institutes of Health - National Institute of Child
Health and Human Development, U.S. Department of Health and Human Services, January, 1990.
171
O'Rourke PP, Crone RK, Vacanti JP, et al: Extracorporeal membrane oxygenation and conventional medical therapy in
neonates with persistent pulmonary hypertension of the newborn: A prospective randomized study. Pediatrics 1989;
84(6):957-963.
Ortiz RM, Cilley RE, Bartlett RH: Extracorporeal membrane oxygenation in pediatric respiratory failure. Pediatr Clin
North Am 1987; 34:39-46.
Payne NR, Kriesmer P, Mammel M, and Meyer CL: Comparison of six ECMO selection criteria and analysis of factors
influencing their accuracy. Pediatr Pulmonol 1991; 11:223-232.
Schumacher RE, Barks JDE, Johnston MV. et al: Right-sided brain lesions in infants following extracorporeal membrane
oxygenation. Pediatrics 1988;82:155-161.
Southgate WM, Howell CG, Kanto WP: Need for and impact on neonatal mortality of extracorporeal membrane
oxygenation in infants of greater than 2500 gram birth weight. Pediatrics 1990; 86:71-74.
Stolar C, Dillon P, Reyes C: Selective use of extracorporeal membrane oxygenation in the management of congenital
diaphragmatic hernia. J Pediatr Surg 1988; 23(3):207-211.
Stolar CJH, Snedecor SM, and Bartlett RH: Extracorporeal membrane oxygenation and neonatal respiratory failure:
experience from the extracorporeal life support organization. J Pediatr Surg 1991; 26:563-571.
Taylor GA, Short BL, Fitz CR: Imaging of cerebrovascular injury in infants treated with extracorporeal membrane
oxygenation. J Pediatr 1989; 114(4):635-639.
Toomasian JM, Snedecor SM, Cornell RG, Cilley RE, Bartlett RH: National experience with extracorporeal membrane
oxygenation for newborn respiratory failure. Trans Am Soc Artif Intern Organs 1988; 34:140-147.
Van Meurs KP, Newman KD, Anderson KD, Short BL: Effect of extracorporeal membrane oxygenation on survival of
infants with congenital diaphragmatic hernia. J Pediatr 1990; 117:954-960.
Wung JT, James LS, Kilchevsky E, James E: Management of infants with severe respiratory failure and persistence of the
fetal circulation, without hyperventilation. Pediatrics 1985; 76(4):488-494.
Table 1: General Inclusion/Exclusion Criteria for ECMO
Gestational Age > 34 Weeks or
Birth Weight > 2,000 Grams
No Significant Coagulopathy or
Uncontrolled Bleeding Complications
No Major Intracranial Hemorrhage
Mechanical Ventilation < 10 - 14 Days
No Uncorrectable Cardiac Lesions
No Lethal Congenital Anomalies
No Evidence of Severe Irreversible Brain Damage
172
Table 2: The Most Commonly Used Neonatal ECMO Criteria
AaDO2:
Range: 605 to 620 torr x 4 - 12 Hours
Oxygen Index (OI):
Range: >35 to >60 x 0.5 to 6 Hours
PaO2:
Range: <35 to <50 mmHg x 2 to 12 Hours
Acidosis and Shock:
pH <7.25 x 2 Hours or with Hypotension
Acute Deterioration
Range: PaO2 < 30 to < 40 mmHg
Note: 50 percent of centers use more than one of the above
Table 4: Average Survival of Infants Treated with ECMO by Diagnosis
Meconium Aspiration Syndrome
RDS/HMD
Congenital Diaphragmatic Hernia
Pneumonia/Sepsis
PPHN
94%
84%
59%
76%
84%
* Data from the ELSO Neonatal Registry, July 1997, n=12,016
DOCUMENT SUMMARY:
Final APPROVAL, 12-92
Reviewed 10-94, approved with changes
Reviewed 07-97, approved with changes
NCH Center Guidelines
I.
Institutional Requirements
A.
Resources required at Children's Hospital
1.
Services
a. Fully equipped neonatal, pediatric and cardiac intensive care unit
b. Blood gas lab 24 hours per day
c. Major laboratory tests available on STAT and critical basis 24 hours/day
d. Blood bank available on a 24-hour basis with all products available
173
e. Radiology, Interventional radiology, Computed tomography scanner and ultrasound
available on a 24-hour basis
2.
Personnel
a. Capable of 1:1 nursing with ICU trained RNs
b. Capable of 1:8 respiratory therapy with ICU trained RRTs
c. Operating room team available on a 24-hour basis
d. ECMO primer available on a 24-hour basis
e. ECMO trained specialist (RN, RRT, or CCP/CCT)
f. Specialties available on a 24-hour basis
(1) Board Certified/ Eligible Pediatric Cardiologist
(2) Board Certified/ Eligible Pediatric Nephrologist
(3) Board Certified/ Eligible Pediatric Geneticist
(4) Board Certified/ Eligible Pediatric Radiologist
(5) Board Certified/ Eligible Pediatric Surgeon
(6) Board Certified/ Eligible Pediatric Intensivist
(7) Board Certified/ Eligible Neonatologist
(8) Board Certified/ Eligible Pediatric Cardiovascular Surgeon
(9) Perfusionist
f.
II.
Consultants
(1) Blood Bank Director
(2) Pediatric Neurosurgeon
(3) Pediatric Pathologist
B.
External Transport Capabilities
1.
Fully trained transport team available on a 24-hour basis
C.
Administrative Requirements
1.
Support of the hospital administration
2.
Medical Directors for the ECMO program
3.
ECMO Coordinator
4.
Multidisciplinary review process for quality assurance
D.
Animal Laboratory for Development of the Program
1.
Training - needs to be available for initial training as well as ongoing refresher courses for the
entire ECMO team.
ECMO Team Composition
A. Medical Directors of ECMO Program
1.
ECMO Medical directors will be appointed:
a. By the section chief of each respective section (PICU/NICU).
b. By the chief of cardiothoracic surgery for the CICU.
2.
Responsible for the following administrative functions of the ECMO program:
a. Oversee the ECMO RN, ECMO RRT, ECMO primers, and physicians involved in the operation
of this program
b. Consultant to the medical team regarding overall medical care.
c. Work directly with the Administration of Nationwide Children's Hospital to insure
coordination and cooperation in the proper execution and ongoing operation of this
program
174
3.
4
2.
3.
4.
Responsible for medical/surgical quality assurance of program
Supervise vivarium training
Determine the criteria for patients receiving ECMO.
Review the operations manual as needed. The ECMO Directors are authorized to make interim
changes in this manual, which will be reviewed by the ECMO coordinator and surgical
coordinator and approved by the ECMO team medical directors.
Responsible for training ECMO surgeons
B. ECMO Coordinator
1.
Maybe a full or part-time (0.6 FTE or greater) position
2.
Maybe a Certified Clinical Perfusionist, RN or RRT trained in all aspects of ECMO
3.
Responsible for team training and management
4.
Responsible for quality assurance with ECMO Medical Directors
5.
Directly supervises and evaluates the ECMO specialists
6.
Maintains and evaluates ECMO equipment and supplies
7.
Responsible for data collection and storage
8.
Capable of assembling, priming, and repairing, the ECMO circuit and for emergency
management of the ECMO circuit
C. Multidisciplinary Team
1.
ECMO primers
a. Member of ECMO Team and responsible to ECMO Coordinators
b. May be full or part-time (0.4 FTE or greater) hospital employee
c. Participates in training of all personnel
d. Assists in evaluation of ECMO equipment, circuit, and procedures
e. Capable of assembly, priming, repairing, the ECMO circuit and for emergency management
of the ECMO circuit
f. Must maintain institutional certification
2.
ECMO Specialist
a. Maybe RN, RRT, or CCP
b. Must complete the ECMO institutional training course successfully and pass the written
exam at 80%.
c. Must complete 40 hours of bedside training followed by successful hands-on check off with
the ECMO coordinator.
d. Must maintain institutional certification
e. Responsible for bedside management of the ECMO patient under the supervision of the
ECMO Physician
f. May be full or part-time (0.4 FTE or greater) hospital employee
g. Responsible to ECMO Coordinator
3.
ECMO Physician
a. Board certified/ Eligible in neonatology, critical care, pediatric surgery or cardiothoracic
surgery
b. Must have completed the institutional ECMO course successfully or equivalent experience
(as determined by the ECMO Medical/Surgical Director).
c. Must maintain competency by:
(1)
Must actively participate in the care of at least 2 patients per year. If this is not
attained, then 4 hours of lab training will be required.
OR
175
(2)
d.
e.
f.
g.
h.
i.
III.
Must submit to laboratory practical exams every 1-2 years or written test
annually.
Provides medical coverage for the ECMO patient
Responsible to the ECMO Medical Directors
Must be willing to participate in the ongoing clinical or laboratory research of the ECMO
team
Must provide in-house coverage
An ECMO attending physician or ECMO fellow will be present in the hospital at all times and
have immediate access to the patient when ECMO is being performed.
Must participate in ECMO Mortality/Morbidity discussions.
4.
ECMO Surgeon
a. Board Certified in pediatric surgery or cardiothoracic surgery
b. Will be competent in cannulation and decannulation techniques and in the management of
surgical complications related to ECMO.
c. Will have successfully completed the yearly surgical ECMO laboratory instruction course
provided by the respective ECMO Surgical Medical Director or participated in 2
cannulation/decannulation surgeries in the last 12 months.
d. Competence will be determined by ECMO Surgical Medical Director.
e. Will acquire training in new or innovative techniques in ECMO cannulation by attending and
successfully completing a surgical ECMO laboratory program.
f. Responsible to the ECMO Surgical Medical Director.
5.
Follow-up Specialist
a. Will be a neonatologist or developmental pediatrician active in the Neonatal Follow-up
Program at Nationwide Children's Hospital
b. Responsible for follow-up of ECMO patients
c. Responsible to the ECMO Medical Directors
6.
Biomedical Engineer
a. Maintains and evaluates ECMO equipment
7.
Others
a. Medical & Surgical Consultants
b. RN
c. RRT
d. Social Workers
e. Physical and Occupational Therapist
Equipment
A.
Maintained and evaluated by the ECMO Coordinator
B.
Minimal equipment required
1.
2.
3.
4.
5.
6.
7.
Blood pump with servo-regulation for arterial and venous line
Heating unit
Extracorporeal circuit
Oxygenator
O2/Air regulator and blender
Activated clotting time device
SvO2 monitoring device
176
C.
IV.
ECMO Training
A.
V.
VI.
Duplicate equipment needed for patient safety
Refer to NCH Guidelines for Training (below)
Research
A.
Ongoing clinical and laboratory research will be conducted by the ECMO Team
B.
Appropriate animal research facilities will be available for training, research, and evaluation of
equipment
Evaluation
A.
Monthly ECMO Team meetings with equipment needs and discussion of administrative topics
B.
Prompt review of any major complication or death
C.
Formal quarterly assessment of:
1.
Mortality
2.
Morbidity
3.
Complications
4.
Team performance
5.
Training
6.
Equipment
7.
Future program needs
8.
Cost effectiveness
Coordinator evaluated yearly by ECMO Medical Directors
Specialists evaluated yearly by ECMO Coordinator
D.
E.
Routine Care
Personnel: Bedside RN
Outcome: Continuity of care for the ECMO patient.
NEONATAL:
1. Vital Signs and Routine Checks:
a. Vital signs documented q hour with MAP per arterial line and CVP if UVC present.
b. Routine NICU monitoring.
2. I’s & O’s q hour. Include; urine, blood, chest tube, NG, and wound drainage.
3. Urine specific gravity, dipstick q 8 hours.
4. Hematest all stools.
5. Diet: NPO
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6. NG to gravity drainage. NG tube changed prn only. No routine changes.
7. Routine skin, wound, and oral care.
8. Betadine dressing (sterile CVL procedure) to cannulation site q shift and prn.
9. ROM to all extremities q shift. Patient may be carefully rotated if stable (NOT ON double lumen VV ECMO) per
physician order, with the assistance of the ECMO specialist.
10. Urinary catheter with routine catheter care. UC is not to be changed without ECMO physician order.
11. Gentle chest physiotherapy and suction q 4 hours and prn.
12. Tracheal aspirate for culture, sensitivity and gram stain as ordered.
13. Patient is heparinized. No IM meds, venipunctures, heelsticks, or bladder crede or cuff blood pressures.
14. No additional heparin is to be given.
15. Draw ABG from arterial line per ECMO physician order, using a non-heparinized syringe.
16. D5W for UAC flush (order a 500cc bag) each day.
17. Prepare all IV medications and solutions for administration. If access to the patient is via the ECMO circuit, then
prepare medications to be administered by the ECMO specialist.
18. Neuro checks q 4 hours to consist of:
a. Pupil size and response to light
b. Assess muscle tone
c. Palpate anterior fontanelle
d. Assess level of consciousness
19. Keep head midline.
PEDIATRIC/ADULT:
1. Cardiac Monitor
2. Vital signs: q 15 min with MAP per arterial line and CVP per SVC, IVC or PA line if present until stable, then q 1 hr.
3. Axillary temperature per nursing routine. No rectal temperatures unless specifically ordered by the ECMO
physician.
4. NG/OG tube to gravity drainage (if < 1 yr). Do not change tube unless ordered by the ECMO physician. Flush
NG/OG tube q 4 hrs and prn to maintain patency.
5. Foley catheter to urimeter with routine catheter care. Do not change catheter unless ordered by the ECMO
Physician.
6. Chest tubes to -20 cm H2O suction.
7. Routine skin and wound care q shift, oral care q 4.
8. Gentle ROM as tolerated:
a. ROM to all extremities q shift. Patient may be carefully rotated (NOT ON Double lumen VV ECMO) with
assistance of ECMO team if stable q 2 hr per physician order.
9. Mild vibratory and percussive chest PT q 4 hours, suction q 2 hours & PRN.
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10. Restraints per unit protocol.
11. Strict I’s & O’s with summary q 24 hrs.
a. I & O q hr. Include urine, blood, chest tube, NG and wound drainage.
12. Urine specific gravity q shift.
13. Hematest all stools.
14. Tracheal aspirate for culture, sensitivity and gram stain per physician order.
15. Patient is heparinized: No IM medications, arterial punctures, veni-punctures, heel sticks, spinal taps or bladder
crede´or cuff blood pressures.
16. Prepare all IV medications and solutions for administration. May be administered by Nurse and/or ECMO
specialist.
17. Neuro checks q 4 hr to consist of:
a. Pupillary size and response to light
b. Assess muscle tone
c. Palpate anterior fontanelle (if present)
d. Assess level of consciousness.
18. Keep head midline if neck cannulation.
19. Cannula dressing change (Q shift):
a. Betadine (< 2 months)
b. Chlorhexidine (> 2 months)
Using the sterile CVL procedure (for neck or groin cannulation sites) change dressing q shift and PRN. Do
not attempt to remove a dressing that is adhered to the wound. If the dressing is adhered to the wound,
contact the ECMO physician for guidance. DO NOT CHANGE CHEST CANNULA DRESSING.
20. Notify attending for parameters out of range.
21. Do not change surgical incision dressing for 24 hr unless heavily blood stained.
22. Cap pacemaker leads when not in use.
23. Temperature control: (Note: all temperature control should initially be managed by the ECMO heater. If there is
a mechanical problem leading to the below situations, an ECMO Primer or Perfusionist should be notified
immediately.)
a. Radiant warmer for infants < 10 kg for temp < 98 _F
b. Heating lamps/warming blanket for temp < 98 _F.
24. Air filters as final stage on all patient venous lines for cyanotic patients and patients with known right to left
vascular shunts.
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Job Descriptions
Coordinator
General summary:
Under indirect supervision, the ECMO Program Coordinator plans, implements, and evaluates the administrative and
direct patient care activities for assigned program team staff. Directs a team of professional and support staff to ensure
assessment, planning, provision and evaluation of patient care to at-risk patients and their families. Provides assistance
with the management of and oversight of patient care activities for this complex program through effective leadership,
including communicating goals and strategies, providing direction and priorities and providing enthusiasm and support.
Principle duties and responsibilities:
The program coordinator communicates, implements and enforces the philosophy, mission, values, standards, policies
and procedures of Nationwide Children’s Hospital.
1. Oversees the supervision of personnel, which includes hiring, work allocation, training, and problem resolution,
evaluates performance and makes recommendations for personnel actions; motivates employees to achieve peak
productivity and performance. .
2. Manages day-to-day operations of the ECMO program, while assuring all performance standards of staff are met.
3. Oversees direct ECMO circuit care and management, and delivery of patient care by all ECMO specialists within the
program.
4. Maintains established institutional policies and procedures, objectives, quality assurance program and safety,
environmental and infection control standards. Develops and implements established goals and objectives for
quality management plans to meet Nationwide Children’s Hospital strategic goals, including:
a) Quarterly ECMO mortality and morbidity review
b) Quarterly ECMO triad meeting
5. Performs administrative management functions, including budget management, statistics and reporting, billing and
reimbursement tracking and related administrative activities for the ECMO program.
a) Collaborates with purchasing and Cardiovascular Perfusion manager to prepare high-cost equipment bids.
6. Monitors, evaluates and justifies monthly budget expenditures and revenue.
7. Develops, reviews and updates protocols, job descriptions, and other paperwork; facilitates communication
amongst ECMO program team, as appropriate.
8. Promotes teamwork by building a team environment and fostering cross-functional collaboration. Represents the
program at internal and external committees, meetings, and conferences.
a) Collaborates with administration, ECMO Medical Directors, Chairs and Physician groups on an ongoing basis to
achieve patient and program goals.
b) Communicates with Nursing and Respiratory Program Managers to facilitate program goals for the ECMO
program.
9. Conducts, coordinates and supports clinical research projects.
10. Continually evaluates literature, equipment and trends related to cardiopulmonary bypass, ECMO/ECLS, and dialysis.
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11. Assists in the collection and review of clinical data to evaluate the ECMO program. Maintains a patient record
database, further provides this information to the ELSO organization for statistical evaluation and comparison to
other ECMO programs both foreign and domestic.
12. Maintains a high level of clinical expertise in the area of cardiopulmonary bypass and ECMO to perform direct
patient care as necessary. Teach precept and mentor ECMO primers and specialists to function in accordance with
standards and expectations. Acts as a clinical consultant to respiratory care, nursing, and medical staff.
13. Evaluates new technologies, equipment, and supplies. Coordinates evaluation of new items through the appropriate
committees.
14. Provides direct care to ECMO patients, performing all functions of the ECMO specialist as necessary. Responsible for
priming the ECMO and dialysis circuit and stabilizing these patients after cannulation. May share clinical
responsibilities, such as priming the ECMO circuit, with the ECMO Primer or other CCP/CCT.
15. Assesses continuing education needs of the ECMO staff. Plans and implements strategies to meet identified needs.
Consults with critical care units in support of their staff education needs.
16. Supports the philosophy and objectives of Nationwide Children's Hospital and assists in interpreting these to referral
agencies and the community.
17. Serves as a clinical resource for Nationwide Children's Hospital departments and referral hospitals inquiring about
ECMO.
18. Ensures a system for tracking and maintaining equipment and supplies.
19. Maintains an active role in state and national professional organizations. Provides expertise to organizations related
to pediatric respiratory care.
20. Plans / facilitates intra-/inter-hospital transport of the ECMO patient.
21. Attends annual ECMO Coordinator meeting held at regional ECMO conferences
Reporting relationships:
Reports to the Director of Cardiovascular Perfusion, and medically to the Medical Director(s) of the ECMO program.
Minimum qualifications/abilities:
1. Ohio Licensed RRT or RN, prefer graduate of a accredited perfusion training program, prefer a Certified Clinical
Perfusionist by the American Board of Cardiovascular Perfusion
2. Bachelor’s Degree is required.
3. Three - five years critical care experience with one year in a Level III Neonatal Intensive Care Unit or Pediatric
Intensive Care Unit preferred.
4. Demonstrated ability to teach utilizing principles of adult learning.
5. High level of initiative, self-direction and accountability for actions required.
6. Strong knowledge of quality improvement methodology, leadership and decision-making skills required.
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7. Ability to maintain composure and function effectively in stressful situations.
8. Effective interpersonal skills required in interactions with department staff, Nationwide Children’s Hospital medical
and nursing staff, other hospital employees, parents/guardians, other agencies and institutions, and the public.
Minimum physical requirements:
Must be able to see, hear, speak, read, and perform manual tasks with or without accommodation and care for oneself
with little or no difficulty. Performance of principal duties and responsibilities may require the ability to travel.
The above list of duties is intended to describe the general nature and level of work performed by people assigned to
this classification. It is not to be construed as an exhaustive list of duties performed by the people so classified, nor is it
intended to limit or modify the right of any supervisor to assign, direct and control the work of employees under his/her
supervision.
ECMO Primer
General Description:
The ECMO primer may be a Perfusionist, Registered Respiratory Therapist or Registered Nurse that has been specially
trained to choose, setup and manage the equipment necessary for providing ECMO support. It is the responsibility of the
ECMO primer to ensure appropriate patient care through continuous interaction with the ECMO physician, the bedside
specialist and by monitoring the patient and all related equipment while working in this capacity. Through this thorough
monitoring, the ECMO primer is expected to identify and make corrections to the related equipment, to maintain the
physicians’ orders. The ECMO primer is additionally required to troubleshoot and resolve patient/equipment issues as
they are presented/encountered by the primer.
Reporting Structure:
Reports to the ECMO Team Coordinator/Manager for administrative and clinical questions or inquiries.
Reports to the ECMO Medical Director/Attending physician regarding the medical management of the ECMO patient.
Duties and Responsibilities:
1. Assembles and primes the appropriate circuit as dictated by the situation.
2. Thoroughly examines the ECMO patient, circuit and medical record on a per shift basis.
3. While in the role of In-HOuse Primer:
a. Verifies sterile circuits assembled and ready for use.
b. Verifies current supplies and identifies deficiencies.
c. Thoroughly inspects bedside and prime carts for appropriate inventory.
d. Performs daily primer check each shift.
e. Attends morning/evening ECMO rounds.
f. Provides lunch/dinner relief to bedside specialist.
g. Downloads ACT machine each shift.
h. Completes patient billing.
i. Completes primer checklist.
j. Is immediately available if needed to place a patient on ECMO.
182
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
k. Is immediately available to assist the bedside specialist with questions, concerns, transportation or
emergencies.
Monitors and adjusts the ECMO circuit per established guidelines or physician order.
Documents all findings on the appropriate patient chart on an ongoing basis.
Recommends appropriate changes to current patient management based on new information or changing patient
status.
Verifies and implements physician orders.
Assists bedside specialist with managing the patient Intake and Output (I’s & O’s) per physician order.
Assists bedside specialist with managing the Activated Clotting Times (ACT’s) as needed to include: adjusting
anticoagulant per guideline or physician order.
Reviews all laboratory and radiographic reports every shift related to the ECMO patient, and reports any irregularity
immediately to ECMO /attending physician and the oncoming primer.
Collaborates with the ECMO/attending physician and other health care professionals to coordinate all tests and
evaluations and transport.
Leads monthly wet labs / animal labs (minimum six/year).
Supports the conduction of research through data/specimen collection.
Performs in the role of ECMO specialist a minimum of 12 hours/month. In the absence of this bedside time, the
primer will be required to lead one of the monthly wet labs or M&M reviews prior to resuming their role of ECMO
primer.
If removed from the role of ECMO primer for more than six months for any reason (leave of absence (LOA), injury,
etc) the ECMO primer will be required to:
a. Review the ECMO guidelines
b. Go through a hands-on check off with the ECMO Coordinator
c. Be mentored preparing an ECMO circuit by a current ECMO primer or coordinator.
Perform other duties as assigned by the ECMO/attending physician, ECMO coordinator or ECMO manager.
Minimum Qualifications/Abilities:
1. Must be a Certified Cardiovascular Perfusionist, Certified Circulation Technologist, Registered Respiratory Therapist
or Registered Nurse with Ohio state licensure if applicable.
2. Current ECMO specialist at Nationwide Children’s Hospital or waiver of this requirement by one of the ECMO
medical directors/manager.
3. Successfully complete the 24 hour ECMO primer training class provided at Nationwide Children’s Hospital.
4. Pass the coordinator practicum after completion of #3 above.
5. Must be able to effectively communicate and perform in stressful situations.
6. Must be able to stand, walk, see, hear, read, speak and write for prolonged periods without accommodations.
7. Must be able to independently lift 30Kg.
8. Must be able to move or reposition patients of any weight or size with assistance.
The above lists are intended to describe the general level and natures of duties performed by ECMO primer and are not
intended to be exclusive/exhaustive in nature.
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ECMO Bedside Specialist
General Description:
The ECMO Specialist may be a Perfusionist, Registered Respiratory Therapist or Registered Nurse that has been trained
to manage the equipment necessary for providing ECMO support. It is the responsibility of the ECMO specialist to
ensure appropriate patient care through the continuous monitoring of the patient and all related equipment while
working in this capacity. Through this thorough monitoring, the ECMO specialist is expected to identify and make
corrections to the related equipment to maintain the physicians’ orders.
Reporting Structure:
Reports to the ECMO Team Coordinator/Manager for administrative and technical items.
Reports to the ECMO medical director/attending physician regarding the medical management of the ECMO patient.
Collaborates with ECMO primer regarding: questions, problems or concerns to include daily management strategies.
Duties and Responsibilities:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Provides constant monitoring of the ECMO patient and circuit.
Monitors and adjusts the ECMO circuit per established guidelines or physician order.
Documents all findings on the appropriate patient char on an ongoing basis.
Recommends appropriate changes to current patient management based on the new information or changing
patient status.
Verifies and implements physician orders.
Manages patient Intake and Output (I’s & O’s) per physician order.
Monitors Activated Clotting Times (ACT’s) at least hourly and adjusts anticoagulant per guideline or physician
order.
Reviews all laboratory and radiographic reports related to the ECMO patient, and reports any irregularity
immediately to ECMO /attending physician.
Collaborates with the ECMO/attending physician, primer and other health care professionals to coordinate all
tests and evaluations.
Participates in monthly wet labs / animal labs (minimum six/year).
Supports the conduction of research through data/specimen collection.
Performs in the role of ECMO specialist a minimum of 12 hours/month. In the absence of this bedside time, the
specialist will be required to attend one of the monthly wet labs prior to resuming their role of ECMO specialist.
If removed from the role of ECMO specialist for more than six months for any reason (leave of absence (LOA),
injury, etc) the ECMO specialist will be required to:
a.
Review the ECMO guidelines
b.
Go through a hands-on check off with the ECMO Coordinator
c.
Be mentored for 12 hours by a current ECMO specialist
Perform other duties as assigned by the ECMO/attending physician, ECMO coordinator or ECMO manager.
Minimum Qualifications/Abilities:
1. Must be a Certified Cardiovascular Perfusionist, Certified Cardiovascular Technician, Registered Respiratory
Therapist or Registered Nurse with Ohio state licensure if applicable.
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2. Two years of Neonatal/Pediatric Intensive care experience or waiver of this requirement by one of the ECMO
medical directors.
3. Successful completion of the Nationwide Children’s Hospital ECMO training course (40 hour didactic program)
minimum passing score 80%. Additionally must complete and document 40hrs of precepted bedside training.
4. Pass the coordinator practicum after completion of #3 above.
5. Must be able to effectively communicate and perform in stressful situations.
6. Must be able to stand, walk, see, hear, read, speak and write for prolonged periods without accommodations.
7. Must be able to independently lift 18Kg.
8. Must be able to move or reposition patients of any weight or size with assistance.
The above lists are intended to describe the general level and natures of duties performed by ECMO specialists and are
not intended to be exclusive/exhaustive in nature.
NCH Guidelines for Training
At Nationwide Children’s, we encompass all of the ELSO recommendations for new specialists and continuing education,
plus have the additional training requirements:
Prerequisites:
1. 2 years Neonatal/Pediatric ICU experience
2. RRT/RN with state licensure, Board certified or Eligible CCP/CCT.
3. Supervisor recommendation
Or previous ECMO experience at another center with a recommendation from their ECMO coordinator
Or CICU/NICU/PICU ECMO Medical Director waiver.
New Specialists:
1. 40 hours of initial training to include:
a. didactic lectures
b. wet laboratory training
c. training in the research facility
2. Written exam covering didactic, wet lab and research facility training
a. The exam must be passed with a score > 80%.
3. Clinical scenario check-off at the end of the training week
a. The check-off must be passed with a score > 75%.
4. 40 hours of ECMO bedside training with a qualified specialist
5. Final clinical scenarios check-off with ECMO coordinator
a. The check-off must be passed with a score > 75%.
Qualified Specialists:
1. Must obtain 12 hours per month of ECMO bedside time or 36 hours in a 3 month span.
2. If this is not accomplished, the specialist must attend the monthly scheduled wet laboratory training and staff
meeting to be eligible to sit ECMO bedside.
3. All specialists are required to attend 6 of 12 yearly monthly training sessions.
185
4. Specialists who do not meet the previous requirements are ineligible to sit ECMO bedside and would need an
additional 12 hours of bedside mentoring by a qualified specialist and are required to repeat the final clinical
check-off.
Coordinators:
1. Attend bimonthly meetings with the ECMO Medical Directors from the NICU, PICU and CICU for updates on
training, budget, equipment status, total ECMO hours for the period, staff hours and pertinent issues.
2. Prime/set up x 3ea circuits per year.
NCH Guidelines for Neonatal ECMO Followup
Prupose: To define the pre/immediate post discharge care of the neonatal ECMO patient.
DISCHARGE PLANNING FOR THE NEONATAL ECMO PATIENT
The transition of the infant's care from the NICU to the community physician is crucial. Responsibility for
medical care must be clear. Additionally, ECMO infants often need more extensive care than is routinely
provided in a primary care facility. Extensive communication between providers in the follow-up clinic, primary
care facility, and parents is important to insure that routine pediatric care and special medical services are
adequately provided. Communication with the infant's pediatrician should start with the discharging physician
prior to discharge.
Prior to discharge the post-ECMO patient should receive:
Neurodevelopmental Assessment
Audiology Evaluation
Eye Exam per individual institution guidelines
MRI
Appointments with primary care physician and necessary medical specialists should be made prior to discharge.
The discharge summary and information about ECMO should be sent to the primary care physician immediately.
1.
2.
AT DISCHARGE
A. Document in the Discharge Summary:
a. Physical Exam findings
b. Notations reflecting growth and feeding
c. Residual lung disease
d. Incision site, type of ECMO (VA or VV)
B. Neurodevelopmental exam
a. Evaluate posture, tone, movement, primitive reflexes, sensory function, and adaptive behavior (this
is facilitated by OT/PT evaluation and consultation)
b. If normal, inform family and address any remaining concerns. Then schedule first follow-up at 1
month with Neonatal Follow-Up Clinic.
c. IF ABNORMAL or Evidence of Seizure Disorder: In addition to Neonatal Follow-Up Clinic, FOLLOWUP AT 1 MONTH with Neonatal/Neurology Clinic.
d. At discharge and at all subsequent evaluation periods:
i. Anthropometrics
ii. Communication with pediatrician
iii. Parent education
OUT PATEINT FOLLOW-UP
I. 1 Month after discharge
186
a. Medical history, physical and neurodevelopmental evaluation-confirm that repeat hearing testing was
scheduled if abnormal in hospital
b. Evaluation of growth and nutrition
II. 3-4 MONTHS OF AGE (corrected age if preterm)
a. Medical history, physical, and neurological exam (as above)
b. Neurodevelopmental Screening (TIMP) by OT/PT
c. Referrals for OT or PT evaluation for treatment if indicated
d. Evaluation of growth and nutrition
III. 8-9 MONTHS OF AGE (corrected age if preterm)
a. Medical history, physical and neurological exam (as above)
b. Neurodevelopmental exam
c. Formal assessment with Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
d. Referrals for OT, PT or Speech evaluations for treatment if indicated
IV. 14 MONTHS OF AGE (corrected age if preterm)
a. Medical history, physical and neurological exam (as above)
b. Neurodevelopmental exam (Bayley-III). Referrals for OT/PT if indicated
c. Language screening (per Bayley-III-Speech referral if delayed communication scores)
d. Nutrition counseling and low cholesterol diet for family
V. 2 YEARS OLD (18-22 months corrected age if preterm)
a. Medical history, physical and neurological exam (as above)
b. Neurodevelopmental exam (Bayley-III). Referrals for OT/PT if indicated
c. Behavioral audiometry through referral to Audiology
d. Language screening (per Bayley-III-Speech referral if delayed communication scores)
e. Nutrition counseling and low cholesterol diet for family
Discharge from the Neonatal Follow-Up Clinic to continue developmental follow-up with a Developmental
Pediatrician as below (every 1-2 years with testing to be determined by Developmental Behavioral Pediatrician and
Psychologist).
VI. THREE YEAR EVALUATION
a. Medical history and physical exam
b. Neurological exam
c. Neurodevelopmental exam: formal assessment with WPPSI-III
d. Language screening (e.g., PPVT-R, verbal scales from WPPSI-III)
e. Social/Adaptive functioning (e.g., ABAS [Adaptive Behavior Assessment System], Child Behavior
Checklist)
VII. FIVE YEAR EVALUATION
a. Medical history and physical/neurological exam
b. Psychological evaluation:
i. General intellectual functioning: WPPSI-III or Stanford-Binet
ii. Language screening: PPVT-R, verbal memory
iii. Visual-motor integration (e.g., Developmental Test of Visual-Motor integration)
iv. Behavior screening (e.g., Child Behavior Checklists or Conners' Behavior)
v. Questionnaires, parent and teacher reports
REFERENCES FOR SELECTED EVATULATION INSTURMENTS:
1. Achenbach, T.M., & Edelbrock, C.S. (1986). Child Behavior Checklist and Youth
187
Self-Report. Burlington, VT: Author.
2. Achenbach, T.M., & Edelbrock, C.S. (1986). Teacher's Report Form. Burlington, CT:
Author.
3. Bayley, N. (1969). Bayley Scales of Infant Development: Birth to Two Years. San
Antonio: The Psychological Corporation.
4. Bayley, N. (2006). Bayley Scales of Infant and Toddler Development–
Third Edition. San Antonio, TX: Harcourt Assessment.
5. Beery, K.E. (1982). Revised Administration, Scoring, and Teaching Manual for the Developmental Test of VisualMotor Integration. Cleveland, OH: Modern Curriculum Press.
6. Conners, C.K. (1985) Conners' Rating Scales. Odessa, FL: Psychological Assessment Resources, Inc.
7. Dunn, L.M. & Dunn, L.M. (1981). Peabody Picture Vocabulary Test - Revised. Circle Pines, MN: American
Guidance Service..
8. Rescorla, L. (1989). The Language Development Survey: A screening tool for delayed language in toddlers.
Journal of Speech and Hearing Disorders, 54(4), 587- 599.
9. Terman, L. M. & Merrill, M.A. (1972). Stanford-Binet Intelligence Scale: Manual for the Third Revision, Form LM. Boston: Houghton Mifflin Company.
10. Thorndike, R.L., Hagen, E.P., & Sattler, J.M. (1986). Guide for Administering and Scoring the Stanford-Binet
Intelligence Scale: Fourth Edition. Chicago: Riverside Publishing.
11. Wechsler, D. (1967/2002). Wechsler Primary and Preschool Scale of Intelligence™ --Third edition (WPPSI™-III).
San Antonio, TX: Harcourt Assessment.
Modified from ELSO Recommendations for Follow-Up for ECMO Patients (Approved 10-94, and Rev. 01-97)
188
Neonatal Follow-up Parent letter
Out Patient Follow-Up after Neonatal ECMO
Extracorporeal membrane oxygenation (ECMO) is a treatment/procedure that provides cardiac and respiratory life
support to patients whose heart and lungs are severely distressed. While the use of ECMO saves lives, patients treated
with ECMO are at risk for central nervous system perfusion abnormalities, silent intracranial hemorrhages, cerebral
infarcts (stroke) and developmental delay even if no cerebral bleed was detected.
Because of this risk, all infants who required ECMO in the neonatal period require close developmental monitoring
following their discharge home from the hospital to make sure that any potential problems are identified in their earliest
stages.
Follow-up visits for your child will be scheduled in the Neonatal Follow-Up Clinic with the first appointment being one
month after your child’s discharge. This first appointment will be to introduce you and your baby to our clinic staff and
to evaluate how your child’s growth and development have progressed since discharge.
Your child’s next appointment will be between 3 and 4 months of age (corrected age is used if infant was born
prematurely). At this visit, the first formal developmental testing will be performed by one of our therapists (either an
Occupational or Physical Therapist). The test that is used is the TIMP or Test of Infant Motor Performance. Based on
testing, physical examination (with physician or nurse practitioner) and review of developmental progress,
recommendations will be made for exercises you can do with your child at home or for more formal therapy, either in
your home (through Help Me Grow) or at a hospital based site.
The next appointment occurs at 8-9 months of age (corrected age if premature). At this visit (and at all subsequent
visits), the Bayley Scales of Infant and Toddler Development (Edition 3) is the assessment tool used to evaluate your
child’s development. Cognitive, Receptive Language, Expressive Language, Fine Motor and Gross Motor skills will be
assessed and evaluated. Recommendations for therapy will be made if indicated based on testing and evaluation by the
physician or nurse practitioner.
Further follow-up will be scheduled at either 14 months of age or just before 2 years of age and this is dependent on
skills present at the 8-9 month old visit. If closer follow-up is indicated then an appointment will be scheduled closer to
14 months of age. As with previous appointments, if therapies are recommended, appropriate referrals will be made.
The last Neonatal Follow-Up Clinic visit will occur when your child is approximately 2 years of age. After the last
Neonatal Follow-Up Clinic visit your child’s developmental care will be transferred to a Developmental Pediatrician in
one of our hospital’s other Developmental Clinics. This first appointment with the Developmental Pediatrician will be
between 6 months and 1 year after your last visit to the Neonatal Clinic. Your child will be followed until at least 5 years
of age. Follow-up will be long term if developmental delays have been identified.
Your infant was placed on ECMO to achieve the best possible developmental outcome. The above described follow-up
plan is in place to ensure that the best possible developmental outcome is achieved.
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NCH Guidelines for ECMO Selection Criteria
General ECMO/ECLS Criteria
A.
Institutional requirements
1.
2.
B.
Criteria predicting a 75% or greater mortality, if conventional therapy is continued should be
used to help determine if patients qualify for ECMO.
Maximal Medical management should be attempted prior to ECMO/ECLS therapy.
Patient eligibility criteria
Patient should ideally meet ALL of the following criteria:
1.
2.
3.
4.
5.
6.
7.
8.
9.
C.
Weight greater than or equal to 2 kilograms
Gestational age 34 weeks or greater
Reversible lung disease
Any significant congenital heart disease must be well defined. The pediatric cardiologist and
pediatric cardiac surgeon must be involved in the decision to offer the patient ECMO.
Intracranial hemorrhage < Grade II
Reasonable chance for intact survival
Failure of maximal medical management (may include 100% oxygen, assisted ventilation,
inotropic support, nitric oxide, etc. if medically warranted)
Compassionate use: Any patient who does not meet the eligibility criteria above shall have a
written statement by the ECMO attending physician justifying the use of ECMO
No known lethal chromosomal or genetic malformations.
ECMO qualifying criteria
Patient must meet ONE of the following criteria while on optimal medical treatment:
1.
2.
3.
4.
5.
6.
7.
PaO2 < 50 mmHg for 2 or more hours
A-a gradient (A-aDO2) > 605 for 4 or more hours
A-aDO2 = (FiO2 (PB – Water vapor) - PaCO2) - PaO2
PB = atmospheric pressure = 745 mmHg in Columbus
Partial pressure H2O vapor = 47mmHg
Oxygenation Index (OI) > 35 for more than 4 hours
OI = (FiO2 x Paw(cmH2O) x 100 / PaO2 )
Paw = mean airway pressure
Acute deterioration = PaO2 < 40 mmHg or acute cardiovascular collapse
Acidosis pH < 7.25 with hypotension for 2 or more hours.
Systolic mean and diastolic blood pressure less than the 5th percentile for weight, > 2 hours
despite volume and pharmacological support.
Note: Infants outside the above parameters can be considered if evaluation by ECMO team
deems use of ECMO appropriate.
Two increasing lactate levels > 2.2 mmol/l
All pediatric respiratory patients will be discussed by the consulting
group consisting of the PICU attending physician, any and all other
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consulting physicians, and the pediatric ECMO physician on call.
Minimum of two must agree.
D.
Exclusionary criteria for respiratory ECMO support
1.
Severe perinatal asphyxia
a. Serum lactate > 25 at any time
b. Blood gas pH 6.8 and base deficit -20 or greater
2.
Patient diagnosed as having a lethal condition that is in its terminal stages of the disease
3.
Patient diagnosed as having a lethal condition that now has a life-threatening complication of
that disease
4.
History of cardiac arrest > 60 minutes
5.
Recent (less than 7 days) CNS hemorrhage.
E.
Relative contraindications
a. Grade II IVH
b. Immunosuppresed patients
F.
Acute decompensation rule
1.
Acute cardiovascular decompensation is defined as any condition that results in serious systemic
hypotension unresponsive to fluid, inotropic and vasoactive pharmacotherapy.
2.
Acute respiratory decompensation is defined as an acute life-threatening hypoxia, hypoxemia,
or an acidosis event unresponsive to optimal ventilator management.
3.
Institution of ECMO/ECLS to stabilize a patient who suffers an acute life-threatening event shall
not be construed as making a fixed commitment to prolonged support. Such support may be
discontinued at any time that it is deemed inappropriate.
G.
Extracorporeal circulation for respiratory failure
1.
Indications are acute, severe, reversible respiratory failure. Conditions include, but are not
exclusive to:
a.
Acute respiratory distress syndrome
b.
Pneumonitis-aspiration, viral or bacterial
c.
Foreign body aspirations
d.
Smoke inhalation
e.
Bronchospastic disease processes (e.g., bronchiolitis,asthma)
f.
Capillary leak syndrome
g.
Barotrauma with airleak syndrome
h.
Acute chest syndrome
H.
Cardiovascular Support
Indications - acute, severe cardiac failure unresponsive to maximal pharmacologic therapy. Patients
may have either severe primary and/or secondary cardiac dysfunction that is life threatening and
unresponsive to all other available measures
Goals of Cardiovascular ECMO
1.
Provide cardiac support until recovery of native myocardial function.
2.
Maximize potential functional myocardial recovery.
3.
Provide adequate tissue perfusion for optimal organ function.
Conditions that may require Cardiovascular Support:
1.
Pre/post- operative cardiac surgery patients
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2.
3.
4.
5.
6.
Patients with potentially reversible low cardiac output syndrome (ie, myocarditis, pericarditis,
cardiomyopathy, arrhythmias, etc.) as demonstrated by
a.) Progressive hypotension
b.) Poor peripheral perfusion
c.) Increasing ventricular filling pressures
Patients with reversible refractory pulmonary hypertensive crises
Cardiac arrest
Patients that are being bridged to definitive operative repair or transplantation
Patients with respiratory dysfunction in addition to cardiac dysfunction
Contraindications to Cardiovascular Support
1.
Irreversible myocardial disease in non-transplant patient.
2.
Prolonged cardiac arrest > 60 minutes
3.
Fixed and elevated pulmonary vascular resistance unless approved as a candidate for transplant
4.
Intractable hemorrhage
5.
Profound neurologic impairment
Transplantation Candidates
1.
Cardiovascular/Respiratory failure patients may be candidates for heart and/or lung
transplantation. Eligibility will be determined by the Cardiothoracic Surgeon and the appropriate
transplant physician. If deemed eligible, these patients may be placed on ECMO/ECLS.
All cardiac patients will be discussed by the Cardiothoracic Surgeon(s) and Cardiologist and
Cardiac Intensivist.
I.
Other Candidates
In the event a patient presents with refractory hypothermia or certain ingestions, ECLS may be
considered.
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