an update on procedural sedation
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An Update on Procedural Sedation
A Primer on the Rules!
Shiva Birdi M.D.
Staff Anesthesiologist and Intensivist
Anesthesiology Institute
Cleveland ClinicMay 14, 2009
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primum non nocereFirst, Do No Harm
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality Improvement
Final Thoughts
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality Improvement
Final Thoughts
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The Old Conscious Sedation
Inconsistent pre-procedure screening
NO requirement for
documentationNO major monitoringstandards
NO quality or
performanceevaluationrequirement
NO credentialingrequired
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Goals of Procedural Sedation
Patient Comfort
Reduce Pain
Reduce Anxiety
Patient SafetyMaintain cardiopulmonary function
Minimize and manage related complications
Improve EfficiencyOptimize procedural conditions
Adequate Recovery
Patient returned to pre-procedural functional
and physiologic level
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A Bit of History
Midazolam (Versed) introduced inUnited States in mid 1980s
86 Deaths in first 5 years of useMajority related to proceduralsedation
Epstein B. Department of Health and Human Services, Office of Epidemiology and Biostatistics,
Center for Drug Evaluation and Research. Data Retrieval Unit HFD-737; June 27, 1989.
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Dangers of Sedation
Bailey et al.
Healthy Volunteers
Given midazolam, fentanyl or bothHypoxemia (92%) and Apnea (50%)
combination of midazolam and fentanyl
Reported to Department of Healthand Human Services
Bailey et al. Anesthesiology. 73(5):826-830, Nov 1990
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Dangers of Sedation
Iber et al. 1
10 pts developed Apnea or CardiopulmonaryArrest during or following endoscopy
Arrowsmith et al. 2
ASGE/FDA Collaborative Study
>21K GI endoscopy procedures
Serious CV complications 5.4 / 1000
Vargo et al. 3
49 pts upper endoscopy
57% with 54 episodes of apnea (>30 sec)
50% with hypoxemia1Iber FL et al. J Clinical Gastroenterology 1992; 14:10913
2Arrowsmith et al. Gastrointestinal Endoscopy, 1991; 37:42173Vargo et al. Gastrointestinal Endoscopy 55:826-831, 2002
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98,000 Preventable Deaths
$17 billion to $29 billion cost
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MAC claims
> 40% with death or
brain damage
Most common injury
Respiratorydepression fromover-sedation
Median Payment
$240,000
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44% judged to be PREVENTABLEBy
Better Monitoring
(pulse oximetry, capnography, improvedvigilance, or audible alarms)
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Mainstream Media
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Dangers of Sedation
Airway Disaster / Aspiration
Respiratory Depression
Cardiovascular ComplicationsParadoxical Response to sedation
Medication Related Events
Inadequate Sedation / Movement
Nausea and Vomiting
Patient Dissatisfaction
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Possible Solutions ?
Provider Education andTraining
Patient Selection
Improved Monitoring
Increased VIGILANCE
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality Improvement
Final Thoughts
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Continuum of Depth of Sedation(Developed by the American Society of Anesthesiologists)
(Approved by ASA House of Delegates on October 13, 1999,and amended on October 27, 2004)
Usually maintainedUsually maintainedCardiovascularFunction
May be inadequateAdequateSpontaneousVentilation
Intervention may berequired
No intervention requiredAirway
Purposeful* responsefollowing repeated orpainful stimulation
Purposeful* response to verbalor tactile stimulationResponsiveness
Deep Sedation /Analgesia
Moderate Sedation / Analgesia(Conscious Sedation)
* Reflex withdrawal from a ainful stimulus is NOT considered a ur oseful res onse
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Moderate Sedation/Analgesia
The Old Conscious Sedation
Patient RESPONDS PURPOSEFULLY
to verbal commands/light stimulationNO airway manipulation required
Spontaneous ventilation maintained
Cardiovascular function usuallymaintained
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Deep Sedation/Analgesia
Patient not easily aroused
Patient RESPONDS PURPOSEFULLY
to repeated or painful stimulationAirway manipulation MAY BErequired
Spontaneous ventilation MAY BEinadequate
Cardiovascular function usually
maintained
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Some Exclusions
Preoperative medications
Patient controlled analgesia
Post-operative or labor analgesia
Pain Management (dressings, burns orangina)
Sedation in the intensive care unit
Sedation for treatment of insomnia
Anxiolysis (single dose)
Drug or alcohol withdrawal or prophylaxis
Treatment of seizure disorders
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As the details
became more andmore transparent
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The Joint Commission waswatching
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and after thorough survey,inspection and review
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STANDARDS UPDATED
Adopted ASA Evidence Based Guidelinesand Depth of Sedation Continuum
Joint Commission on Accreditation ofHealthcare Organizations: "Standards andIntents for Sedation and Anesthesia Care,"
in Revisions to Anesthesia Care Standards,Comprehensive Accreditation Manual forHospitals. Oakbrook Terrace, Ill., JointCommission on Accreditation of Healthcare
Organizations, 2001. (updated 2004)
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Comparable Care Mandate
There must be no decrement
in the care delivered to patientsduring their entire continuum of
care within the hospital.
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Bottom Line
All conscious sedation areas (OR
and non-OR) must have processes(pre-sedation assessment, intra-procedure monitoring, discharge
criteria), facilities, equipment,and personnel similar to thoseutilized for MAC delivered byqualified anesthesia providers in theOR.
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JCAHO Standards
Assessment of Patients (PE)
Care of Patients (TX)
Improving Organizational
Performance (PI)
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JCAHO Standards
Assessment of Patients (PE)PE.1.8.1
Any patient for whom moderate or deep sedation oranesthesia is contemplated receives a pre-sedation or
pre-anesthesia assessmentPE.1.8.2
Before anesthesia, the patient is determined to be anappropriate candidate for anesthesia.
PE.1.7.3
The patient is re-evaluated immediately beforeanesthesia induction
PE.1.8.4
The patient's postoperative status is assessed onadmission to and discharge from the post-anesthesia
recovery area Cohen et al. ASA Newsletter. May 2001
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JCAHO Standards
Care of Patients (TX)TX.2.0
Moderate or deep sedation and anesthesia are providedby qualified individuals
TX.2.1A pre-sedation or pre-anesthesia assessment isperformed for each patient before beginning moderate ordeep sedation and before anesthesia induction.
TX.2.1.1
Each patient's moderate or deep sedation and anesthesiacare is planned.
TX.2.2
Sedation and anesthesia options and risks are discussedwith the patient and family prior to administration
Cohen et al. ASA Newsletter. May 2001
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JCAHO Standards
Care of Patients (TX) contd.TX.2.
Each patient's physiological status is monitored duringsedation or anesthesia administration
TX.2.4The patient's post-procedure status is assessed onadmission to and before discharge from the post-sedation or post-anesthesia recovery area
TX.2.4.1
Patients are discharged from the post-sedation or post-anesthesia recovery area and the organization by aqualified LIP or according to criteria approved by themedical staff.
TX.3.5.5
Emergency medications are consistently available,controlled and secure in the harmac and atient care
Cohen et al. ASA Newsletter. May 2001
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JCAHO Standards
Improving Organizational Performance(PI)
PI.4.
Data are systematically aggregated and analyzedon an ongoing basis
PI.4.2.
The organization compares its performance overtime and with other sources of information
PI.4.3.
Undesirable patterns or trends in performance andsentinel events are intensively analyzed .
PI.4.4.
The organization identifies changes that will lead toCohen et al. ASA Newsletter. May 2001
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What this meansfor the Provider?
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality Improvement
Final Thoughts
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Patient Selection
Planned Procedure
Associated physiologic derangements
Patients Medical StatusCoMorbid Conditions
Preoperative Status is Optimized
Airway Exam
NPO Guidelines
Intended Level of Sedation/Analgesia
Must be decided in advance
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Pre-Procedure Assessment
Focused H&P
Summary of Patient Current Condition
Review Medications and Allergies
Review of Co-Morbid DiseasesPrevious adverse rxn to sedation/anesthesia
Last PO Intake (time and nature)
Cardiac, Pulmonary and Airway exam
MUST be reviewed immediately prior toprocedure for any changes
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ASA Classification
E: after the Class would represent an
emergency
f
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ASA Classification
ASA Closed Claims Study (for sedation)1age greater than 70 years
ASA physical status III to V
THESE RESULTED IN HIGHER LITIGATION
1Bhananker, S et al. Anesthesiology. 2006:Feb;104(2):228-234.
ll
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Mallampati Score
ll S
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Mallampati Score
MAY BE HIGHRISK FORAIRWAY
DIFFICULTIES
OTHER RELAVANT HISTORY:
H/O Snoring
Thick NeckDifficulty with Neck ROM
Hi h Ri k P i
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High Risk Patients
Extremes of Age
Severe cardiac,pulmonary, renal,
or hepatic disease(ASA class III)
Potential difficultintubation(MP score III)
Pregnancy
H/o drug abuse orEtOH abuse
H/o difficulty withsedation oranesthesia
DEEP Sedation isplanned
Hi h Ri k P ti t
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High Risk Patients
Extremes of Age
Severe cardiac,pulmonary, renal,
or hepatic disease(ASA class III)
Potential difficultintubation(MP score III)
Pregnancy
H/o drug abuse orEtOH abuse
H/o difficulty withsedation oranesthesia
DEEP Sedation isplanned
IF ONE or MORE of these risk factorsAnd DEEP sedation planned
CONSIDER GETTING ANESTHESIOLOGY INVOLVED
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Ohi B d f N i
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Ohio Board of Nursing( July 2007)
RN (not CRNA) cannot engage inadministration of medications thatinduce DEEP SEDATION or GENERAL
ANESTHESIA
RN cannot engage in activities thatdivert attention away from thepatient
www.nursing.ohio.gov
R i t d N C d ti l
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Registered Nurse Credentials
INSTITUTIONAL CREDENTIALING REQUIREMENTS +
Supervised by LIP (Moderate Sedation Only)
PharmacologyAge- and weight- related dosage, reversals
Monitoring
Pulse oximetry, Cardiac monitors
Level of consciousness assessmentPain assessment
Arrhythmia recognition
Basic Airway management
***Recognition of Deep Sedation***
S d ti P ti
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Sedation Practice(JCAHO and ASA Guideline)
Understand Sedation Continuum
Difficult to predict individual patientresponse to sedation
MUST be able to RESCUE patientfrom next level of sedation
MODERATE DEEP
DEEP GA
RESCUE d RETURN
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RESCUE and RETURN(JCAHO and ASA Guideline)
Sedation Practitioner must be able toRESCUE a patient one level abovethe intended level of sedation
After RESCUE the patient isRETURNED to the original intendedlevel of sedation
Ph i i C d ti li
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Physician Credentialing
Each organization is free to define how it willdetermine that the individuals are able to performthe rescue (JCAHO Feb, 2009)
Physicians administering or supervisingmoderate or deep sedation/analgesia should haveappropriate education and training (ACS ST-46
April 2004)
Only physicianswith adequate training,education and licensure to administer moderatesedation should supervise (ASA Statement
October 2006)
Ph i i C d ti li
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Physician Credentialing
ER, ICU excluded
Competency and Training in:
Oxygen delivery systemsBasic cardiovascular physiology
Pharmacology of sedatives and reversalagents
Understanding and knowledge ofrequired and emergency equipment
KNOW HOW TO CALL FOR HELP !
M d t S d ti
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Moderate Sedation
Sedation/Analgesia Training andPrivileging
Institution dependent
(ex. Online or Live Sedation Course followed by aquiz)
***Recognition of Deep Sedation***
Basic Resuscitative TechniquesBCLS (renew every years)
Demonstrate proficiency in airwaymana ement with ba -mask ventilation
Deep Sedation
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Deep Sedation
Deep Sedation
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Deep Sedation
Requirements for Moderate Sedation +
Advanced Resuscitative Techniques
ACLS, ATLS (renew every 2 years)
Demonstrate ability to manage associatedcomplications including slipping into General
Anesthesia
Advanced airway management skills including useof airway assist devices and managecompromised airways
ex. Airwa worksho offered at institution
Equipment
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Equipment
Oxygen Supply
Pulse Oximetry
Blood Pressure
*EKG* (as indicated for at risk patient inmoderate but a MUST for deep)
*Capnography* (beneficial adjunct for
monitoring adequacy of ventilation)Does not replace examination of patient
Emergency equipment
Suction
Crash Cart
Special Note
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Special Note
Supplemental oxygen decreasesincidence of hypoxemia
Adequate OXYGENATION does notmean adequate VENTILATION
REVERSAL agents (Naloxone,Flumazenil) must be available
IV access must be maintainedthroughout the procedure andrecovery phase
Procedural Sedation Record
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Procedural Sedation Record
Performed by a Dedicated Qualified Assistant
Document Vitals at regular intervals
Moderate sedation (q 10 min)
Deep sedation (q 5 min)
Pain and Sedation Scoring System
Oxygen Saturation and Respiratory Rate
Level of consciousness (ex. Ramsey Scale)
Verbal and visual exam by monitoring assistant
Airway Manipulation Interventions
Chin lift, Jaw thrust, adjunct airway, MV, etc.
May assist in post procedure audit
Recovery
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Recovery
Standards of Monitoring continue
Appropriate staff available
Documentation continues
In-patients
must return to baseline function andphysiological status prior to return to RNF
Out-patientsalert and oriented
stable vital signs
baseline ambulation status
pain and nausea well controlled
Objectives
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality
ImprovementFinal Thoughts
Quality Improvement
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Quality Improvement
Hospital Quality Improvement
Certification of Procedure Sedation Site
Oversight of sedation practice and evaluation
of patient outcomesMonitor and Identify System Failures toReduce Incidence of Sentinal Events*
*A sentinel event is an unexpected occurrenceinvolving death or serious physical orpsychological injury, or the risk thereof .
*Joint Commission Standards
Quality Improvement
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Quality Improvement
Department Quality Improvement
Applies to each department providingModerate Sedation
Systematically gather and analyze dataon a continuous basis
Establish Department Specific Quality
Markers and ThresholdsDevelop Quality Reports that arereviewed by Hospital QI
Perform regular reviews
Examples of Quality Markers
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Examples of Quality Markers
ANY need to Rescue patients fromunintended deeper level of sedation
ANY usage of airway manipulationmaneuvers
ANY major change in VS (Sat/BP)
ANY major cardiopulmonary eventANY use of reversal agents
ANY prolonged recovery phase
Objectives
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Objectives
Background
Continuum of Sedation
New JCAHO StandardsPatient Selection & Credentialing
Process and Quality Improvement
Final Thoughts
Final Thoughts
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Final Thoughts
PATIENT SELECTION IS CRITICAL
Anesthesia involvement for patientsat high risk for sedationcomplications
Titration of sedative / analgesics
Adequate oxygenation DOES NOTequal adequate ventilation
EARLY RECOGNITION OF DEEPERTHAN INTENDED SEDATION
Key Resources
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Key Resources
Continuum of Depth of Sedation
ASA Sedation Guidelines for Non-Anesthesiologists
Pass the Survey!
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Pass the Survey!
CREDENTIALING MUST BEMAINTAINED!
EVERY PATIENTS PROCEDURALSEDATION PLAN SHOULD BEINDIVIDUALIZED
Avoid COOKBOOK Techniques
Pass the Survey
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Pass the Survey
Quality and Process ImprovementStrategies employed across theInstitution
Compliance with JCAHO ComparableCare Mandate
PRIMARY GOAL: PATIENT SAFETY
Conclusion
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Conclusion
Procedural Sedation is extremely
Safe and Effective
when performed on well selected,adequately informed patients, by
appropriately trained, credentialed,
and well supported providers.
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ADEQUATE PREPARATION LEADS TO A
SAFE, EFFECTIVE AND SATISFACTORY
EXPERIENCE
QUESTIONS ?
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QUESTIONS ?
Todays Presentation and supportingdocuments available online:
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