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OBJECTIVES
Upon completion of this activity, participants
will be able to:



Identify all key critical patient safety risk
issues in pediatric sedation.
Describe key personnel and system
components necessary for delivery of safe
pediatric sedation services, and explain the
role of each.
Propose a “best practice” model for pediatric
sedation, and analyze the differences
between this and the existing model at the
participant’s institution.
PATIENT SAFETY ISSUES IN SEDATION
~ preview ~
1.
2.
3.
4.
5.
The importance of respiratory depression in
sedation adverse events.
The different levels of sedation.
The AAP and ASA Guidelines for sedation.
The essential components required to conduct
safe pediatric sedation.
The importance of a systematic approach to
sedation that promotes safety and efficacy.
SEDATIVE DRUGS
1.
All sedative drugs suppress the CNS
2.
Respiratory depression: the most significant
adverse effect following sedative drug
administration
a. Impaired airway control - the single
most serious adverse event
b. Hypoventilation
3.
Depth of sedation is a continuum
mild sedation general anesthesia
4.
The greater depth of sedation the greater risk
IX
X
inhibition
Nasal
Segment
P(O)
Pharyngeal
Segment
Tracheal
Segment
P(-)
THE UPPER AIRWAY
Pharyngeal collapse during sedation
Minute ventilation
(l/min)
sedation
pCO2
VENTILATION
HYPOVENTILATION DURING SEDATION
AAP and ASA Practice
Guidelines for Sedation
~ Expert Opinion and Consensus ~
Developed in response to:
the growing number of sedations
performed by non-anesthesiologists
outside the operating room setting
&
adverse sedation events
- AAP GUIDELINES FOR MONITORING AND
MANAGEMENT OF PEDIATRIC PATIENTS DURING
AND AFTER SEDATION FOR DIAGNOSTIC AND
THERAPEUTIC PROCEDURES
* Pediatrics 1985: defined Conscious and Deep Sedation
* Pediatrics 1992: Pulse Oximetry monitoring included
* Pediatrics 2002: Addendum to 1992
* Pediatrics 2006 ?: Conscious and Deep Sedation
redefined as Minimal, Moderate and Deep Sedation
- ASA PRACTICE GUIDELINES FOR SEDATION AND
ANALGESIA BY NON ANESTHESIOLOGISTS
* Anesthesiology 2002; 96:1004-1017 - Defined Sedation Levels:
Minimal, Moderate and Deep
SEDATION LEVELS
• General Description
• Responsiveness
• Airway
• Ventilation
• Cardiovascular
SEDATION LEVELS
Minimal
• General Description
“Anxiolysis”
• Responsiveness
“appropriate”
• Airway
unaffected
• Ventilation
unaffected
• Cardiovascular
unaffected
Risk
of
Adverse
Event
No
Sedation
Mild
Sedation
SEDATION LEVELS
Minimal
Moderate
• General Description
“Anxiolysis”
“Conscious”
• Responsiveness
“appropriate”
“Purposeful” to light
stimulation
• Airway
unaffected
No intervention
• Ventilation
unaffected
Adequate
• Cardiovascular
unaffected
Maintained
Risk
of
Adverse
Event
No
Sedation
Mild
Sedation
Moderate
Sedation
SEDATION LEVELS
Minimal
Moderate
Deep
• General Description
“Anxiolysis”
“Conscious”
“Deep sleep”
• Responsiveness
“appropriate”
“Purposeful” to light
stimulation
“Purposeful” to pain
stimulation
• Airway
Unaffected
No intervention
(±) Intervention
• Ventilation
Unaffected
Adequate
(±) Inadequate
• Cardiovascular
Unaffected
Maintained
(±) Maintained
Risk
of
Adverse
Event
No
Sedation
Mild
Sedation
Moderate
Sedation
Deep
Sedation
SYSTEMS ANALYSIS OF
ADVERSE DRUG EVENTS
JAMA 1995; 274: 35-43
334 errors led to 264 ADEs
“REASON” FOR OCCURANCE
*1.
*2.
3.
4.
5.
6.
7.
Lack of knowledge of drug: dose, choice (29%)
Lack of patient information (18%)
Rule violation (10%)
Slips and memory lapses
Transcription errors
Faulty  system
Communication among services
*1 & 2 involved in ~ 50% of errors
ANALYSIS OF 2000 ANESTHETIC INCIDENTS
~ the AIMS Report ~
Anaesth Intens Care 1993;21:506-520
Report of 2000 unintended incidents which reduced
or had potential to reduce patient safety.
1.
2.
3.
4.
5.
Active Error immediate precursors
Knowledge based
35%
Rule - based
33%
Technical
13%
Slips - Lapses
10%
No error
9%
Latent Errors “weakness” in system
Equipment, personnel, communication, faculty, etc
.
ANALYSIS OF 2000 ANESTHETIC INCIDENTS
~ the AIMS Report ~
Anaesth Intens Care 1993;21:506-520
Factors Reducing Occurrence of Adverse Outcomes
1.
2.
3.
4.
5.
6.
Experience (knowledge)
Monitor Detection
Equipment re √
Skilled assistance
Supervisor
Staff ∆
35%
36%
15%
12%
9%
ADVERSE SEDATION EVENTS IN
CHILDREN BY NONANESTHESIOLOGISTS
Anesth Analg 1997;85:1207
1. Total sedations: 1140 (~ 75% Chloral) - prospective
assessment of QA tool
2. 239 (20 %) adverse events
• 13%: inadequate sedation
• 5.5%: oxygen desaturation (< 90%)
3. Oxygen desaturation in 46 (5.4%) of 854 chloral
hydrate sedations
4. Risk factors: ASA III, IV and age < 1 yo
PEDIATRIC SEDATION
the1990’s = sedation safety concerns
Adverse Sedation Events in Pediatrics
National volunteer reporting of adverse
sedation events in children.
Cote CJ, et al. Pediatrics, 2000
represents the“tip of the ice berg”
ADVERSE SEDATION EVENTS IN
PEDIATRICS
~ Sources ~
• FDA Adverse Drug Event Report
• US Pharmacopoeia
• Pediatric specialist survey
95 events reported
(1) Cote CJ, et al. Pediatrics 2000;105:805
Critical Incident Analysis
(2) Cote CJ,et al. Pediatrics 2000;106:633
Sedative Medication Analysis
ADVERSE SEDATION EVENTS
n=95
~ Critical Incident Analysis ~
Pediatrics 2000;105:805
•
60 deaths / permanent CNS injury
•
80%: 1st event respiratory
•
Poor outcome associated with:
1. Inadequate resuscitation (outpt >> inpt)
2. Inadequate monitoring, particularly SpO2
3. Inadequate initial evaluation
4. Inadequate recovery phase
ADVERSE SEDATION EVENTS
n=95
~ Sedative Drug Analysis ~
Pediatrics 2000;106:633
1.
Drug - drug interaction (n=44), especially >3
drugs
2.
Drug overdose (n=39)
3.
Drug administration at home and by non-medical
personnel
4.
Deaths after discharge associated with drugs
with long elimination half life
5.
No association with drug class or route
1.
THE TEAM - Knowledge/Skills
a. Nurse
b. Physician
2. THE SETTING - Resources
a. Medications
b. Equipment
c. The “Milieu”
3. THE STRUCTURE - Organization and Process
a. Protocols
b. Policy
THE SETTING
THE TEAM
THE STRUCTURE
THE
FOUNDATION
PERFORMING SAFE AND EFFECTIVE SEDATION
FOUNDATIONS OF
SEDATION
THE TEAM
1. Personnel
a. The Practitioner
b. Support Personnel
2. Specific Training
a. Pharmacology of sedatives - analgesics
b. Pharmacology of antagonists
c. Basic Life Support
d. Advanced Life Support
JCAHO© 2000
Revisions to Anesthesia Care Standards
Comprehensive Accreditation Manual for Hospitals
“Qualified individuals” conducting sedations must
possess education, training and experience in:
1. Evaluating patients prior to moderate or deep
sedation
2. Rescuing patients who slip into a “deeper than
desired” level of sedation or anesthesia.
3. Managing a compromised airway during a
procedure.
4. Handling a compromised cardiovascular system
during a procedure.
FOUNDATIONS OF
SEDATION
THE SETTING
Conducive environment to conducting safe
and effective sedation
S - Suction
O - Oxygen
A - Airway equipment
P - Pharmacologic agents
M - Monitors
S - Special equipment
FOUNDATIONS OF
SEDATION
1.
2.
3.
THE STRUCTURE
Pre-Sedation/Procedure Phase
Evaluation
a. History: medical diagnoses, sedation anesthesia history, medications, allergies,
airway history
b. Exam: airway, lungs, heart, CNS (other
relevant)
Patient - Family counseling: risks,
alternatives, informed consent
Fasting status
FOUNDATIONS OF
SEDATION
THE STRUCTURE
Sedation/Procedure Phase
Monitoring & Personnel
SEDATION LEVELS
• General Description
• Responsiveness
• Airway
• Ventilation
• Cardiovascular
• Monitoring
• Personnel
SEDATION LEVELS
Minimal
• General Description
“Anxiolysis”
• Responsiveness
“appropriate”
• Airway
Unaffected
• Ventilation
Unaffected
• Cardiovascular
Unaffected
• Monitoring
Observation &
intermittent
assessment
• Personnel
Responsible
practitioner
SEDATION LEVELS
Minimal
Moderate
• General Description
“Anxiolysis”
“Conscious”
• Responsiveness
“appropriate”
“Purposeful” to light
stimulation
• Airway
Unaffected
No intervention
• Ventilation
Unaffected
Adequate
• Cardiovascular
Unaffected
Maintained
Observation &
intermittent
assessment
• Pulse oximetry-
• Monitoring
continuous
• Heart rate (SpO2)continuous
• Intermittent recording
of RR and BP
• Personnel
Responsible
practitioner
* Practitioner immediately available
* Support personnel present, may conduct
interruptible tasks
SEDATION LEVELS
Minimal
Moderate
Deep
• General Description
“Anxiolysis”
“Conscious”
“Deep sleep”
• Responsiveness
“appropriate”
“Purposeful” to light
stimulation
“Purposeful” to
pain stimulation
• Airway
Unaffected
No intervention
(±) Intervention
• Ventilation
Unaffected
Adequate
(±) Inadequate
• Cardiovascular
Unaffected
Maintained
(±) Maintained
Observation &
intermittent
assessment
• Pulse oximetrycontinuous
• Pulse oximetry continuous
• Heart rate (SpO2)-
• ECG - continuous
• Monitoring
continuous
• Intermittent recording
of RR and BP
• Personnel
Responsible
practitioner
* Practitioner immediately available
* Support personnel present, may conduct
interruptible tasks
• BP every 3 minutes
• (±) EtCO2, precordial
stethoscope
* Practitioner - present
* Support Personnel present
GENERAL APPROACH TO
CONDUCTING SAFE AND
EFFECTIVE PEDIATRIC
PROCEDURAL SEDATION
FOUNDATIONS OF
SEDATION
STRUCTURE
Post Sedation Phase
1. Recover phase
2. Discharge criteria
3. Followup
THE PATIENT
THE SETTING
THE TEAM
THE STRUCTURE
THE
FOUNDATION
PERFORMING SAFE AND EFFECTIVE SEDATION
SAFE AND EFFECTIVE SEDATION
THE VARIABLES
1. THE PATIENT
a. Medical Diagnosis
b. ASA level
2. THE PROCEDURE
a. Non-invasive
b. Invasive
3. THE SEDATIVE
a. Sedative - Hypnotic
b. Sedative - Analgesic
PEDIATRIC SEDATION
PATIENT ASA DEFINITIONS:
Class
Description
Examples
Sedation
Suitability
1
A normally healthy patient
Unremarkable medical history
Excellent
2
A patient with mild
systemic disease (no
functional limitation)
Mild asthma, controlled
seizure disorder, anemia,
controlled diabetes mellitus
Generally good
3
A patient with severe
systemic disease (definite
functional limitation)
Moderate-to-severe asthma,
poorly controlled seizure,
pneumonia, poorly controlled
IDDM, moderate obesity.
Intermediate to
poor; consider
benefits relative
to risks
4
A patient with severe
systemic disease that is a
constant threat to life
Severe bronchopulmonary
dysplasia, sepsis, advanced
degrees of pulmonary,
cardiac, hepatic, renal, or
endocrine insufficiency
Poor, benefits
rarely outweigh
risks
(from N Engl J Med 2000;342:913)
SEDATION RISK FACTORS
~ Patient Characteristics ~
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Airway obstruction history (snoring, stridor)
OSA
Poor control of airway secretions
Craniofacial anomalies
Chronic lung disease
Myocardial dysfunction
Mental status changes
Poorly controlled seizures
Hydrocephalous, Increased ICP
Acute illness - URI, cough, GI symptoms
GERD
Bowel obstruction
Obesity
PEDIATRIC SEDATION
THE PROCEDURE
1) What are the desired clinical effects?
2) How quickly are effects desired?
3) What is the desired duration of
effects?
4) Any adverse “other” clinical effects?
DRUG CONCENTRATION
ADVERSE
EFFECTS
B
DESIRED
EFFECTS
THERAPEUTIC
WINDOW
A
INADEQUATE
EFFECTS
TIME
THERAPEUTIC WINDOW
SAFE-EFFECTIVE PEDIATRIC SEDATION
LOW DEGREE
OF IMMOBILITY
LOW
DEGREE
OF PAIN
HIGH
DEGREE
OF PAIN
HIGH DEGREE
OF IMMOBILITY
ANXIETY - FEAR
SLEEP
Anxiolytic/”Light” Sleeper
Hypnotic
ANXIETY-FEAR/
DISCOMFORT (pain)
SLEEP/PAIN
Analgesic and/or Anxiolytic
Analgesic +
Sedative/Hypnotic
DOES APPLICATION OF THE AAP/ASA
GUIDELINES DECREASE THE RISK OF
PEDIATRIC PROCEDURAL SEDATION?
1)
2)
3)
Pediatrics 2002;109:236-243
Prospective QI evaluation of coded sedation records
(prospective data collection, retrospective analysis)
960 records reviewed: 4.2% complication rate
a. Conscious Sedation complication rate - 3.8%
b. Deep Sedation complication rate - 9.2%
Risk reduction
a. Pre-sedation risk assessment
b. Adherence to guidelines (e.g. monitoring)
c. Avoidance of Deep Sedation
DOES A STRUCTURED SEDATION
PROGRAM#1 Improve Sedation Efficacy?
#2 Improve Sedation Safety?
INCIDENCE AND NATURE OF ADVERSE EVENTS
DURING PEDIATRIC SEDATION/ANESTHESIA
FOR PROCEDURES OUTSIDE THE OPERATING ROOM:
Report From the Pediatric Sedation Research Consortium
Pediatrics 2006;118:1087
1. Prospective database collection - 26 institutions
30,037 sedation/anesthesia encounters
2. Adverse events a. Total - 1 per 29 sedations
b. SpO2 < 90% (> 30 sec) - 1 per 63 sedations
3. Unplanned treatments
a. Total - 1 per 89 sedations
b. Airway/Ventilation - 1 per 200 sedations
4. No deaths
Serious morbidity - 2 cases with high ASA level
INCIDENCE AND NATURE OF ADVERSE EVENTS
DURING PEDIATRIC SEDATION/ANESTHESIA
FOR PROCEDURES OUTSIDE THEOPERATING ROOM:
Report From the Pediatric Sedation Research Consortium
Pediatrics 2006;118:1087
~ Conclusions ~
1. Most common adverse events
a. Airway obstruction, apnea
b. Secretions
c. Vomiting
2. Core competencies identified
a. Management of airway obstruction
b. Management of respiratory depression
3. Sedation risk and ASA status - showed importance of:
a. “rescue” capabilities
b. patient risk assessment
SAFE AND EFFECTIVE
PEDIATRIC SEDATION:
~ What we have learned ~
1. Takes EDUCATION
2. Takes ORGANIZATION
3. Requires a safe and effective SETTING
4. Takes WORK, TIME, and COMMITTMENT
5. Is SERIOUS BUSINESS
Appendix: Joint Commission
Sedation Related Standards,
2006
• Reference: Comprehensive Accreditation
Manual for Hospitals: The Official
Handbook 2006 (camh)
• Abbreviations:
– PC: section on Provision of Care, Treatment
and Services
– PI: section on Improving Organization
Performance
– IM: section on Management of Information
– LIP: Licensed Independent practitioner
– EP: Element of Performance – components of
each standard, scored during survey.
Standard PC.13.20
Operative or other procedures and/or
administration of moderate or deep sedation or
anesthesia.
•
Elements of Performance (EP)
1. Sufficient numbers of qualified staff, to
evaluate the patient, help with the
procedure, provide sedation or
anesthesia, monitor, and recover the
patient.
Standard PC 13.20 EP’s Continued
2. Individuals administering moderate or deep sedation and
anesthesia are qualified and have the appropriate
credentials to manage patients at whatever level of sedation
or anesthesia is achieved, either intentionally or
unintentionally.
– Notes: at a minimum: competency-based education,
training and experience in the following
– Evaluating patients before performing moderate or
deep sedation and anesthesia
– Performing the moderate or deep sedation and
anesthesia, including rescuing patients who slip into
a deeper-than-desired level of sedation or analgesia.
– Moderate Sedation – Qualified to rescue from
deep sedation – can manage a compromised
airway and provide adequate oxygenation and
ventilation
– Deep Sedation- Qualified to rescue from general
anesthesia, competent to mange an unstable
cardiovascular system as well as a compromised
airway and inadequate oxygenation and
ventilation.
PC.13.20, EP’s Continued
3. A registered nurse supervises
perioperative nursing care.
4. Appropriate equipment to monitor the
patient’s physiologic status is available.
(also see PC.13.30)
5. Appropriate equipment to administer IV
fluids and drugs, including blood and
blood components, is available as
needed.
6. Resuscitation capabilities are available.
PC.13.20, EP’s Continued
EP-s 7-10 must occur prior to administration of
moderate, deep sedation and anesthesia
7.
8.
The anticipated needs of the patient are
assessed to plan for the appropriate level of
post procedure care.
Perprocedural education, treatments, and
services are provided according to the plan
of care, treatment and services.
PC.13.20, EP’s Continued
9.
Conduct a “time out” immediately before starting
the procedure as described in the Universal
Protocol.
•
National Patient Safety Goals – Goal 9,
Preoperative verification
• Final verification of the correct patient,
procedure, site and, implants
• Active Communication among all members of
the surgical/procedure team, consistently
initiated by a designated member of the team,
conducted in a “fail-safe” mode, that is, the
procedure is not started until any questions or
concerns are resolved.
PC.13.20, EP’s Continued
10. A presedation or preanesthesia assessment is
conducted
11. Before sedating or anesthetizing a patient, a
licensed independent practitioner with appropriate
clinical privileges plans or concurs with the planned
anesthesia.
12. The patient is reevaluated immediately before
moderate or deep sedation and before anesthesia
induction.
Standard PC. 13.30
Monitoring, Patients are monitored during the procedure and or
administration of moderate or deep sedation or anesthesia.
1.
Appropriate methods are used to continuously monitor
oxygenation, ventilation, and circulation during
procedures that may affect the patient’s physiological
status.
•
Notes - VS – HR, pulse ox, BP, at regular intervals.
EKG or use of continuous cardiac monitoring
device, in patients with significant cardiovascular
disease or when dysrhythmias are anticipated or
detected.
2. The procedure and/or administration of moderate or
deep sedation or anesthesia for each patient is
documented in the medical record. (also see Standard
IM.6.30)
Standard PC.13.40
Post Sedation, Anesthesia Monitoring EP’s
1.
2.
3.
4.
5.
The patient’s status is assessed immediately after the
procedure and/or administration of moderate or deep
sedation or anesthesia.
Each patient’s physiological status, mental status, and
pain level are monitored
Monitoring is at a level consistent with the potential
effect of the procedure and/or sedation or anesthesia.
Patients are discharged from the recovery area and the
hospital by a qualified licensed independent
practitioner or according to rigorously applied criteria
approved by the clinical leaders.
Patients who have received sedation or anesthesia in
the outpatient setting are discharged in the company of
a responsible, designated adult.
Standard IM.6.30
The medical record thoroughly documents operative or other high
risk procedures and the use of moderate or deep sedation or
anesthesia.
• EP 6. – Postoperative documentation records the
patient’s discharge from the postsedation or
postanesthesia care area by the responsible licensed
independent practitioner or according to discharge
criteria.
• EP 7 – The use of approved discharge criteria to
determine the patient’s readiness for discharge is
documented in the medical record.
• EP 8 – Postoperative documentation records the name
of the LIP responsible for discharge.
Standard PI.2.20
Undesirable patterns or trends in
performance are analyzed
• EP 8. An analysis is performed for adverse
events or patterns of adverse events during
moderate or deep sedation and anesthesia
use.