Download SAT AND SBT Protocol Definitions for Cusp 4 MVP-VAP

SAT AND SBT PROTOCOL
DEFINITIONS FOR
CUSP 4 MVP-VAP
Protocol Definitions and Recommendations for
Spontaneous Awakening Trials (SAT) and Spontaneous Breathing Trials (SBT)
Johns Hopkins Armstrong Institute for Patient Safety and Quality
Table of Contents
I.
JHU Armstrong Institute - Protocol for SAT and SBT
II.
SAT and SBT Protocol Definitions for CUSP for VAP: EVAP
1.
Summary of Pertinent Points – Part I
2.
Spontaneous Awakening Trial (SAT)
3.
Spontaneous Breathing Trial (SBT)
4.
Results
5.
Summary of Pertinent Points – Part II
6. Recommendations
7. Clinical Practice Guidelines
III.
References
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I. Johns Hopkins University Armstrong Institute –
Protocol for Spontaneous Awakening (SAT) and
Spontaneous Breathing Trial (SBT)
Spontaneous Awakening (SAT) and Spontaneous Breathing Trial
(SBT) Protocol:
A wake up and breathe protocol using both the SAT and SBT can significantly reduce
the number of days patients are on mechanical ventilation. Girard, et al. illustrated that
paired, the SAT and SBT reduced the number of days patients were on mechanical
ventilation (3.1 mean difference, 95% CI 0.7-5.6; p=0.02), with a concomitant reduction
in the length of hospital stay (4 day difference) when compared to SBT alone.4 We are
using the paired SAT and SBT model developed by Girard, et al. for this collaborative.
Based on this protocol, patients first undergo a screening for the SAT. If the patient
passes the screen, they undergo the SAT. Patients are then monitored for up to 4 hours
for wakefulness. If the SAT is passed during this time, then the patient undergoes an
SBT screen, followed by an SBT.4
The SAT consists of two parts, a safety screen and the trial. (Please see flow diagram
on page 6 below.) The safety screen attempts to assure the trials will not be used when
contraindicated. Patients pass the screen unless:
1.
2.
3.
4.
5.
They are receiving a sedative infusion for active seizures or alcohol withdrawal
They are receiving escalating doses of sedative for agitation
They are receiving neuromuscular blockers
They have evidence of active myocardial ischemia in prior 24 hours
They have evidence of increased intracranial pressure
If the patient passes the safety screen, the patient then undergoes the SAT. All sedative
and analgesics used for the purpose of sedation are stopped. Analgesics used to
control pain are continued.
The goal is that the patient is either wakeful to the extent such that he/she can do three
out of four simple tasks on request: open their eyes, look at their caregiver, squeeze
the hand or put out their tongue. This technique to assess wakefulness was used by
Kress, et al., as well as in multiple subsequent randomized control trials during the past
ten years.3 Moreover, wakefulness is assessed over a period of 4 hours, in keeping with
the Girard, et al. protocol.4
Note: the patient is considered to have passed the prior to stopping sedatives if the
patient responds to the verbal commands detailed above. In such cases, a patient is
deemed to be lightly sedated, and the sedative may be stopped at the provider’s
discretion.
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Again, the goal of the SAT is for the patient to be lightly sedated. The level of sedation
is assessed by the patient’s ability to perform three out of four tasks on request: open
their eyes, look at their caregiver, squeeze the hand or put out their tongue. If sedatives
are stopped, the patient is monitored for the following failure criteria:
1. sustained anxiety
2. agitation
3. pain
4. a respiratory rate of 35 breaths/minute for >= 5 minutes
5. an SpO2 of less than 88% for >=5 minutes
6. an acute cardiac dysrhythmia
7. two or more signs of respiratory distress
a. tachycardia
b. bradycardia
c. use of accessory muscles
d. abdominal paradox
e. diaphoresis
f. marked dyspnea
If the patient fails the SAT, and the patient’s sedatives have been stopped, they are restarted at one half the prior dosage and titrated as needed. The goal of this protocol is
to ensure that patients are lightly sedated, in keeping with the Society of Critical Care
Medicine’s (SCCM) latest practice guideline.5
If a patient passes the SAT, the patient is assessed for the SBT safety screen. Patients
pass the screen if:
1. they have adequate oxygenation (SpO2 >=88% or an F1O2 of <=50% and a
PEEP <=8 cm H2O)
2. any spontaneous inspiratory effort in a 5-min period
3. no agitation
4. no significant use of vasopressors or inotropes
5. no evidence of increased intracranial pressure
If a patient fails the SBT safety screen they are reassessed for SAT the following day. If
the patient passes the SBT safety screen, they undergo the SBT. The SBT consists of
allowing the patient to breathe through either a T-tube circuit of a ventilatory circuit with
CPAP of 5cm H2O or pressure support ventilation of less than 7cm H2O. An SBT may
last from 30 to 120 minutes, at the provider’s discretion. Patients pass the trial if they
don’t develop any of the following failure criteria during this time period:
1.
2.
3.
4.
5.
respiratory rate of more than 35 or less than 8 breaths per min for 5 min or longer
hypoxemia (SpO2 < 88% for >=5 min)
abrupt change in mental status
an acute cardiac arrhythmia
two or more signs of respiratory distress
a. tachycardia
b. bradycardia
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c.
d.
e.
f.
use of accessory muscles
abdominal paradox
diaphoresis
marked dyspnea
If a patient fails the SBT, he/she is reassessed for SAT the following day. If a patient
passes the SBT, the patient’s physicians are notified for evaluation for possible
extubation.
Note: This SBT technique is based on the recommendations made by a weaning task
force convened by multiple national and international critical care societies.6
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Figure 1: SAT/SBT Safety Screen and Trial4
Johns Hopkins Armstrong Institute for Patient Safety and Quality
II. Spontaneous Awakening Trials (SAT) and
Spontaneous Breathing Trials (SBT) Protocol Definitions
for a Comprehensive Unit-Based Safety Program (CUSP)
for Ventilator- Associated Pneumonia (VAP):
Eliminate Ventilator-Associated Pneumonia (EVAP)
Our protocol is based on the literature cited below.
Summary of Pertinent Points - Part I4:
URL Link:
http://www.sciencedirect.com/science/article/pii/S0140673608601051
This is a randomized controlled trial. Outcomes compare the use of the SAT vs. SBT,
as well as SAT and SBT combined. SBT and SAT below are from the same protocol.
Spontaneous Awakening Trials (SAT)4:
“In accordance with the SAT protocol, patients in the intervention group were
assessed every morning with an SAT safety screen. SATs were prescribed by protocol
only for patients in the intervention group, although patients in the control group were
not prevented from undergoing SATs if the managing clinician felt that they were
indicated. Patients passed the screen unless they were receiving a sedative infusion for
active seizures or alcohol withdrawal, were receiving escalating sedative doses due to
ongoing agitation, were receiving neuromuscular blockers, had evidence of active
myocardial ischaemia in the previous 24 h, or had evidence of increased intracranial
pressure. Patients who failed the screen were reassessed the following morning.
Patients who passed the screen underwent an SAT: all sedatives and analgesics
used for sedation were interrupted. Analgesics needed for active pain were continued.
Patients were monitored by intensive-care staff or study personnel for up to 4 h.
Patients passed the SAT if they opened their eyes to verbal stimuli or tolerated sedative
interruption for 4 h or more without exhibiting failure criteria. Patients failed the SAT if
they developed sustained anxiety, agitation, or pain, a respiratory rate of more than 35
breaths per min for 5 min or longer, an SpO2 of less than 88% for 5 min or longer, an
acute cardiac dysrhythmia, or two or more signs of respiratory distress, including
tachycardia, bradycardia, use of accessory muscles, abdominal paradox, diaphoresis,
or marked dyspnoea. When patients failed an SAT, intensive-care staff restarted
sedatives at half the previous dose and then titrated the medications to achieve patient
comfort. Patients who passed the SAT were immediately managed with the SBT
protocol.”
Johns Hopkins Armstrong Institute for Patient Safety and Quality
Spontaneous Breathing Trials (SBT)4:
“In accordance with the SBT protocol, patients in the control group were
assessed every morning with an SBT safety screen. Patients passed the screen if they
had adequate oxygenation (oxygen saturation [SpO2] ≥88% on a fraction of inspired
oxygen [FIO2] ≤50% and a positive end-expiratory pressure [PEEP] ≤8 cm H2O), any
spontaneous inspiratory effort in a 5-min period, no agitation, no evidence of myocardial
ischaemia in the previous 24 h, no significant use of vasopressors or inotropes
(dopamine or dobutamine ≥5 μg/kg per min, norepinephrine ≥2 μg/min, or vasopressin
or milrinone at any dose), and no evidence of increased intracranial pressure. Patients
who failed the screen were reassessed the following morning.
Patients who passed underwent an SBT: ventilatory support was removed, and
the patient was allowed to breathe through either a T-tube circuit or a ventilatory circuit
with continuous positive airway pressure of 5 cm H2O or pressure support ventilation of
less than 7 cm H2O. No change was made in FIO2 or PEEP during the SBT. Patients
failed the SBT if they developed a respiratory rate of more than 35 or less than eight
breaths per min for 5 min or longer, hypoxaemia (SpO2 <88% for ≥5 min), abrupt
changes in mental status, an acute cardiac arrhythmia, or two or more signs of
respiratory distress, including tachycardia (>130 bpm), bradycardia (<60 bpm), use of
accessory muscles, abdominal paradox, diaphoresis, or marked dyspnoea. Patients
who failed the SBT were ventilated immediately with the ventilator settings used before
the trial. Patients passed the SBT if they did not develop any failure criteria during a
120-min trial. If the SBT was successful, the patients’ physicians were notified verbally.”
Results4:
“150 (90%) patients in the intervention group passed an SAT safety screen;
these patients underwent 895 SATs. Analgesics were continued for pain during 132
(15%) of these SATs. Clinicians discontinued the sedatives administered to 52 (31%)
patients in the control group before at least one SBT. The number of patients in each
group treated with benzodiazepines, opiates, or propofol was similar, as was the
cumulative dose of propofol. The cumulative benzodiazepine dose was higher in the
control group than in the intervention group. Only 45 (27%) patients in the control group
and 31 (18%) patients in the intervention group received haloperidol (p = 0.07).
Patients in the intervention group spent more days breathing without assistance
than those in the control group (3・1 mean ventilator-free days difference, 95% CI 0.7 –
5.6; p = 0.02). Additionally, the intervention protocol resulted in discharge about 4 days
earlier from both intensive care and from the hospital. There was no significant
interaction between study center and treatment with respect to the number of ventilatorfree days. The duration of coma was significantly shorter in the intervention group than
in the control group, whereas the duration of delirium was similar between the two
groups. Of the assessable patients, delirium occurred in 124 (74%) in the intervention
group and 119 (71%) in the control group (p = 0.66).”
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Summary of Pertinent Points – Part II3:
URL Link:
http://www.nejm.org/doi/full/10.1056/NEJM200005183422002
“Each day, we assessed each patient’s mental status with respect to
wakefulness. A patient was considered “awake” if he or she was able to perform at least
three of the following four actions, which could be assessed objectively: open the eyes
in response to a voice, use the eyes to follow the investigator on request, squeeze a
hand on request, and stick out the tongue on request.”
Recommendations from this Review Article6:
URL Link:
http://www.ersj.org.uk/content/29/5/1033.full.pdf+html
“Weaning should be considered as early as possible in patients receiving mechanical
ventilation; a majority of patients can be successfully weaned on the first attempt. SBT
is the major diagnostic test to determine if patients can be successfully extubated. The
initial SBT should last 30 min and consist of either T-tube breathing or low levels of PS
(5–8 cmH2O in adults; f10 cmH2O in pediatric patients) with or without 5 cmH2O PEEP.
SIMV should be avoided as a weaning modality. Weaning protocols are most valuable
in hospitals in which physicians otherwise do not adhere to standardized weaning
guidelines.”
Clinical Practice Guidelines for the Management of Pain, Agitation,
and Delirium in Adult Patients in the Intensive Care Unit5:
URL Link:
http://www.ncbi.nlm.nih.gov/pubmed/23269131
“Maintaining light levels of sedation in adult ICU patients is associated with improved
clinical outcomes (e.g., shorter duration of mechanical ventilation and a shorter ICU
length of stay). Maintaining light levels of sedation increases the physiologic stress
response, but is not associated with an increased incidence of myocardial ischemia.
The association between depth of sedation and psychological stress in these patients
remains unclear. We recommend that sedative medications be titrated to maintain a
light rather than deep level of sedation in adult ICU patients, unless clinically
contraindicated.”
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III. References
1. Ely EW, Baker AM, Dunagan DP, et al. Effect on the duration of mechanical
ventilation of identifying patients capable of breathing spontaneously. N Engl J Med.
1996; 335(25):1864-1869.
2. Brook AD, Ahrens TS, Schaiff R, et al. Effect of a nursing-implemented sedation
protocol on the duration of mechanical ventilation. Crit Care Med. 1999;
27(12):2609-2615.
3. Kress J, Pohlman A, O'Connor M, Hall J. Daily interruption of sedative infusion in
critically ill undergoing mechanical ventilation. N.Engl.J.Med. 2000; 342:1471-1477.
4. Girard TD, Kress JP, Fuchs BD, et al. Efficacy and safety of a paired sedation and
ventilator weaning protocol for mechanically ventilated patients in intensive care
(awakening and breathing controlled trial): A randomised controlled trial. Lancet.
2008; 371(9607):126-134.
5. Barr J, Graser GL, Puntillo K, et al. Clinical practice guidelines for the management
of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care
Med. 2013; 41(1):263-306.
6. Boles JM, Bion J, Connors A, et al. Weaning from mechanical ventilation. Eur Respir
J. 2007; 29(5):1033-1056.
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