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  • In addition to the individual performing the procedure.

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  • Patient Safety Issues in Sedation: Pitfalls and Best Practices Thursday, September 28, 2006 12:00 – 1:00 p.m. EDT
    • Moderator:
    • Marlene R. Miller, MD, MSc, FAAP
    • Director of Quality and Safety Initiatives
    • Johns Hopkins Children’s Center
    • Baltimore, Maryland
  • This activity was funded through an educational grant from the Physicians’ Foundation for Health Systems Excellence.
  • D isclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities Grid
    • The AAP CME program aims to develop, maintain, and increase the competency, skills, and professional performance of pediatric healthcare professionals by providing high quality, relevant, accessible and cost-effective educational experiences. The AAP CME program provides activities to meet the participants’ identified education needs and to support their lifelong learning towards a goal of improving care for children and families ( AAP CME Program Mission Statement, August 2004).
    • The AAP recognizes that there are a variety of financial relationships between individuals and commercial interests that require review to identify possible conflicts of interest in a CME activity. The “AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities” is designed to ensure quality, objective, balanced, and scientifically rigorous AAP CME activities by identifying and resolving all potential conflicts of interest prior to the confirmation of service of those in a position to influence and/or control CME content. The AAP has taken steps to resolve any potential conflicts of interest.
    • All AAP CME activities will strictly adhere to the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. In accordance with these Standards, the following decisions will be made free of the control of a commercial interest: identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the CME activity.
    • The purpose of this policy is to ensure all potential conflicts of interest are identified and mechanisms to resolve them prior to the CME activity are implemented in ways that are consistent with the public good. The AAP is committed to providing learners with commercially unbiased CME activities.
  • DISCLOSURES
  • DISCLOSURES
  • DISCLOSURES
  • CME CREDIT
    • The American Academy of Pediatrics (AAP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
    •  
    • The AAP designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.
    •  
    • This activity is acceptable for up to 1.0 AAP credit. This credit can be applied toward the AAP CME/CPD Award available to Fellows and Candidate Fellows of the American Academy of Pediatrics.
  • OTHER CREDIT
    • This webinar is approved by the National Association of Pediatric Nurse Practitioners (NAPNAP) for 1.2 NAPNAP contact hours of which 0.0 contain pharmacology (Rx) content. The AAP is designated as Agency #17. Upon completion of the program, each participant desiring NAPNAP contact hours should send a completed certificate of attendance, along with the required recording fee ($10 for NAPNAP members, $15 for nonmembers), to the NAPNAP National Office at 20 Brace Road, Suite 200, Cherry Hill, NJ 08034-2633.
    •  
    • The American Academy of Physician Assistants accepts AMA PRA Category 1 Credit(s) TM from organizations accredited by the ACCME .
    • Featured Speaker:
    • Greg Hollman, MD, FAAP
    • Medical Director, Pediatric Sedation Program
    • Director, Pediatric Critical Care Fellowship Program
    • University of Wisconsin Children’s Hospital
    • Madison, Wisconsin
    • Featured Speaker:
    • Timothy E. Corden, MD, FAAP
    • Associate Professor of Pediatrics
    • Associate Director, Pediatric Critical Care Medicine
    • Co-Director, Policy Core, Injury Research Center
    • Medical College of Wisconsin
    • Milwaukee, Wisconsin
  • 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 ~
    • 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
    • All sedative drugs suppress the CNS
    • Respiratory depression: the most significant adverse effect following sedative drug administration
    • a. Impaired airway control - the single
    • most serious adverse event
    • b. Hypoventilation
    • Depth of sedation is a continuum
    • mild sedation  general anesthesia
    • 4. The greater depth of sedation the greater risk
  • Pharyngeal Segment Nasal Segment Tracheal Segment THE UPPER AIRWAY Pharyngeal collapse during sedation  inhibition  IX X P(-) P(O)
  • pCO 2 Minute ventilation (l/min) VENTILATION HYPOVENTILATION DURING SEDATION 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 • Responsiveness • Airway • Ventilation • Cardiovascular • General Description
  • SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation • Responsiveness • Airway • Ventilation • Cardiovascular • General Description “ appropriate” unaffected unaffected unaffected “ Anxiolysis” Minimal
  • SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation Moderate Sedation • Responsiveness • Airway • Ventilation • Cardiovascular • General Description “ Purposeful” to light stimulation No intervention Adequate Maintained “ appropriate” unaffected unaffected unaffected “ Conscious” “ Anxiolysis” Moderate Minimal
  • SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation Moderate Sedation Deep Sedation • Responsiveness • Airway • Ventilation • Cardiovascular • General Description “ Purposeful” to pain stimulation (±) Intervention (±) Inadequate (±) Maintained “ Purposeful” to light stimulation No intervention Adequate Maintained “ appropriate” Unaffected Unaffected Unaffected “ Deep sleep ” “ Conscious” “ Anxiolysis” Deep Moderate Minimal
  • 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  immediate precursors 1. Knowledge based 35% 2. Rule - based 33% 3. Technical 13% 4. Slips - Lapses 10% 5. 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. 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. Inadequate monitoring, particularly SpO 2 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
    • THE TEAM - Knowledge/Skills
    • a. Nurse
    • b. Physician
    PERFORMING SAFE AND EFFECTIVE SEDATION
    • THE SETTING - Resources
    • a. Medications
    • b. Equipment
    • c. The “Milieu”
    • THE STRUCTURE - Organization and Process
    • a. Protocols
    • b. Policy
    THE STRUCTURE THE TEAM THE SETTING THE FOUNDATION
  • 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
    • 1. Evaluating patients prior to moderate or deep sedation
    • Rescuing patients who slip into a “deeper than desired” level of sedation or anesthesia.
    • Managing a compromised airway during a procedure.
    • Handling a compromised cardiovascular system during a procedure.
    Revisions to Anesthesia Care Standards Comprehensive Accreditation Manual for Hospitals “ Qualified individuals” conducting sedations must possess education, training and experience in:
  • 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 THE STRUCTURE Pre-Sedation/Procedure Phase 1. Evaluation a. History: medical diagnoses, sedation - anesthesia history, medications, allergies, airway history b. Exam: airway, lungs, heart, CNS (other relevant) 2. Patient - Family counseling: risks, alternatives, informed consent 3. Fasting status
  • FOUNDATIONS OF SEDATION THE STRUCTURE Sedation/Procedure Phase Monitoring & Personnel
  • SEDATION LEVELS • Personnel • Monitoring • Responsiveness • Airway • Ventilation • Cardiovascular • General Description
  • SEDATION LEVELS • Personnel • Monitoring • Responsiveness • Airway • Ventilation • Cardiovascular • General Description Responsible practitioner Observation & intermittent assessment “ appropriate” Unaffected Unaffected Unaffected “ Anxiolysis” Minimal
  • SEDATION LEVELS • Personnel • Monitoring • Responsiveness • Airway • Ventilation • Cardiovascular • General Description * Practitioner - immediately available * Support personnel - present, may conduct interruptible tasks Responsible practitioner • Pulse oximetry- continuous • Heart rate (SpO 2 )- continuous • Intermittent recording of RR and BP Observation & intermittent assessment “ Purposeful” to light stimulation No intervention Adequate Maintained “ appropriate” Unaffected Unaffected Unaffected “ Conscious” “ Anxiolysis” Moderate Minimal
  • SEDATION LEVELS • Personnel • Monitoring • Responsiveness • Airway • Ventilation • Cardiovascular • General Description * Practitioner - present * Support Personnel - present * Practitioner - immediately available * Support personnel - present, may conduct interruptible tasks Responsible practitioner • Pulse oximetry - continuous • ECG - continuous • BP every 3 minutes • (±) EtCO 2 , precordial stethoscope • Pulse oximetry- continuous • Heart rate (SpO 2 )- continuous • Intermittent recording of RR and BP Observation & intermittent assessment “ Purposeful” to pain stimulation (±) Intervention (±) Inadequate (±) Maintained “ Purposeful” to light stimulation No intervention Adequate Maintained “ appropriate” Unaffected Unaffected Unaffected “ Deep sleep ” “ Conscious” “ Anxiolysis” Deep Moderate Minimal
  • 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
  • PERFORMING SAFE AND EFFECTIVE SEDATION THE STRUCTURE THE TEAM THE SETTING THE FOUNDATION THE PROCEDURE THE SEDATIVE THE PATIENT
  • SAFE AND EFFECTIVE SEDATION THE VARIABLES
    • THE PATIENT
    • a. Medical Diagnosis
    • b. ASA level
    • THE PROCEDURE
    • a. Non-invasive
    • b. Invasive
    • 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 Mild asthma, controlled Generally good systemic disease (no seizure disorder, anemia, functional limitation) controlled diabetes mellitus 3 A patient with severe Moderate-to-severe asthma, Intermediate to systemic disease (definite poorly controlled seizure, poor; consider functional limitation) pneumonia, poorly controlled benefits relative IDDM, moderate obesity. to risks 4 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, risks cardiac, hepatic, renal, or endocrine insufficiency (from N Engl J Med 2000;342:913)
    • SEDATION RISK FACTORS
    • ~ Patient Characteristics ~
    • 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?
  • A B DRUG CONCENTRATION THERAPEUTIC WINDOW ADVERSE EFFECTS INADEQUATE EFFECTS DESIRED EFFECTS TIME THERAPEUTIC WINDOW
  • SAFE-EFFECTIVE PEDIATRIC SEDATION LOW DEGREE OF IMMOBILITY HIGH DEGREE OF IMMOBILITY HIGH DEGREE OF PAIN LOW DEGREE OF PAIN ANXIETY - FEAR Anxiolytic/”Light” Sleeper SLEEP Hypnotic 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?
    • Pediatrics 2002;109:236-243
    • 1) 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
    • 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
    • Unplanned treatments
    • a. Total - 1 per 89 sedations
    • b. Airway/Ventilation - 1 per 200 sedations
    • 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 ~
    • Most common adverse events
    • a. Airway obstruction, apnea
    • b. Secretions
    • c. Vomiting
    • Core competencies identified
    • a. Management of airway obstruction
    • b. Management of respiratory depression
    • Sedation risk and ASA status - showed importance of:
    • a. “rescue” capabilities
    • b. patient risk assessment
  • SAFE AND EFFECTIVE PEDIATRIC SEDATION: ~ What we have learned ~
    • 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)
      • 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
    • A registered nurse supervises perioperative nursing care.
    • Appropriate equipment to monitor the patient’s physiologic status is available. (also see PC.13.30)
    • Appropriate equipment to administer IV fluids and drugs, including blood and blood components, is available as needed.
    • 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
    • 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
    • A presedation or preanesthesia assessment is conducted
    • Before sedating or anesthetizing a patient, a licensed independent practitioner with appropriate clinical privileges plans or concurs with the planned anesthesia.
    • 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.
    • 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.
    • 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
    • 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.