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 participant ’ “ best practice s institution.

” model for pediatric sedation, and analyze the differences between this and the existing model at the

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

P(O)

Nasal Segment

IX



inhibition



X

Pharyngeal Segment Tracheal Segment

P(-) THE UPPER AIRWAY Pharyngeal collapse during sedation

sedation pCO 2 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

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular SEDATION LEVELS

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

unaffected unaffected unaffected Risk of Adverse Event

No Sedation Mild Sedation

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

unaffected unaffected unaffected Moderate “Conscious”

“Purposeful” to light stimulation

No intervention Adequate Maintained Risk of Adverse Event

No Sedation Mild Sedation Moderate Sedation

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

Unaffected Unaffected Unaffected Moderate “Conscious”

“Purposeful” to light stimulation

No intervention Adequate Maintained Deep “Deep sleep ”

“Purposeful” to pain stimulation

(

±

) Intervention (

±

) Inadequate (

±

) 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.

Lack of knowledge of drug:

dose, choice (29%)

*2.

Lack of patient information

(18%)

3. Rule violation

(10%)

4. Slips and memory lapses 5. Transcription errors 6. Faulty



system 7. 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.

Active Error



1. Knowledge based 2. Rule - based 3. Technical 4. Slips - Lapses 5. No error

immediate precursors

35% 33% 13% 10% 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. Experience (knowledge) 35% 2. Monitor Detection 36% 3.

Equipment re √ 15% 4. Skilled assistance 12% 5. Supervisor 9% 6.

Staff ∆

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.

3.

4.

Inadequate monitoring, particularly SpO Inadequate initial evaluation Inadequate recovery phase 2

1.

ADVERSE SEDATION EVENTS n=95 ~ Sedative Drug Analysis ~

Pediatrics 2000;106:633

Drug drugs

- drug interaction

(n=44), especially >3 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.

2.

3.

THE TEAM - Knowledge/Skills a.

Nurse b.

Physician THE SETTING - Resources a.

b.

c.

Medications Equipment The “Milieu” THE STRUCTURE - Organization and Process a.

b.

Protocols 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

1.

2.

3.

FOUNDATIONS OF SEDATION

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

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular • Monitoring • Personnel SEDATION LEVELS

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular • Monitoring SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

Unaffected Unaffected Unaffected Observation & intermittent assessment • Personnel Responsible practitioner

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular • Monitoring • Personnel SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

Unaffected Unaffected Unaffected Observation & intermittent assessment Responsible practitioner Moderate “Conscious”

“Purposeful” to light stimulation

No intervention Adequate Maintained • Pulse oximetry continuous • Heart rate (SpO 2 ) continuous • Intermittent recording of RR and BP * Practitioner immediately available * Support personnel present, may conduct interruptible tasks

• General Description • Responsiveness • Airway • Ventilation • Cardiovascular • Monitoring • Personnel SEDATION LEVELS Minimal “Anxiolysis”

“appropriate”

Unaffected Unaffected Unaffected Observation & intermittent assessment Responsible practitioner Moderate “Conscious”

“Purposeful” to light stimulation

No intervention Adequate Maintained • Pulse oximetry continuous • Heart rate (SpO 2 ) continuous • Intermittent recording of RR and BP * Practitioner immediately available * Support personnel present, may conduct interruptible tasks Deep “Deep sleep ”

“Purposeful” to pain stimulation

(

±

) Intervention (

±

) Inadequate (

±

) Maintained • Pulse oximetry continuous • ECG - continuous • BP every 3 minutes • (

±

) EtCO 2 , 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 SETTING THE PATIENT 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

1 2 3 4

Description Examples

A normally healthy patient A patient with mild systemic disease (no functional limitation) Unremarkable medical history Mild asthma, controlled seizure disorder, anemia, controlled diabetes mellitus

Sedation Suitability

Excellent Generally good A patient with severe systemic disease (definite Moderate-to-severe asthma, poorly controlled seizure, Intermediate to poor; consider functional limitation) pneumonia, poorly controlled benefits relative IDDM, moderate obesity. to risks A patient with severe Severe bronchopulmonary Poor, benefits systemic disease that is a dysplasia, sepsis, advanced rarely outweigh constant threat to life degrees of pulmonary, cardiac, hepatic, renal, or risks endocrine insufficiency

(from N Engl J Med 2000;342:913)

SEDATION RISK FACTORS ~ Patient Characteristics ~ 1.

2.

3.

4.

5.

6.

7.

Airway obstruction history (snoring, stridor) OSA Poor control of airway secretions Craniofacial anomalies Chronic lung disease Myocardial dysfunction Mental status changes 8.

9.

Poorly controlled seizures Hydrocephalous, Increased ICP 10. Acute illness - URI, cough, GI symptoms 11. GERD 12. Bowel obstruction 13. 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?

B ADVERSE EFFECTS DESIRED EFFECTS

THERAPEUTIC WINDOW

A INADEQUATE EFFECTS TIME THERAPEUTIC WINDOW

SAFE-EFFECTIVE PEDIATRIC SEDATION

LOW DEGREE OF IMMOBILITY HIGH DEGREE OF IMMOBILITY LOW DEGREE OF PAIN ANXIETY - FEAR Anxiolytic/”Light” Sleeper SLEEP Hypnotic HIGH DEGREE OF PAIN ANXIETY-FEAR/ DISCOMFORT (pain) Analgesic and/or Anxiolytic SLEEP/PAIN 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.

b.

c.

Pre-sedation risk assessment Adherence to guidelines (e.g. monitoring) 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. SpO 2 < 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 ventilation – can manage a compromised airway and provide adequate oxygenation and

–

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.

2.

•

Appropriate methods are used to continuously monitor oxygenation, ventilation, and circulation during procedures that may affect the patient’s physiological status.

Notes - VS detected.

– 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 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)

1.

2.

3.

4.

5.

Standard PC.13.40

Post Sedation, Anesthesia Monitoring EP’s 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.