CLINICAL PRACTICE POLICY PAGE: 1 OF 6 PURPOSE: These policies will allow clinicians to provide their patients with the benefits of procedural sedation and analgesia while minimizing the associated risks. Procedural sedation/analgesia allows patients to tolerate unpleasant procedures by relieving anxiety and discomfort. In children and uncooperative adults, sedation/analgesia may expedite the conduct of procedures where the patient s movements must be controlled or minimized. Excessive sedation/analgesia may result in cardiac or respiratory depression, which must be rapidly recognized and appropriately managed to avoid the risk of hypoxic brain damage, cardiac arrest or death. Conversely, inadequate sedation/analgesia may result in undue patient discomfort or actual patient injury because of lack of cooperation or adverse physiological response to stress. This policy establishes a uniform level of care and defines the parameters to be followed for the administration and recovery of patients receiving procedural sedation/analgesia at Hartford Hospital. Personnel administering sedation and analgesia for procedures must be qualified and have the appropriate credentials to manage patients at the level of sedation intentioned and have the ability to recognize a deeper level of sedation and either seek immediate help or return the patient to the intended level of sedation. SCOPE: This policy applies to clinical situations in which patients receive moderate sedation, deep sedation, or general anesthesia for procedures outside of the operating room, in any setting, by any route, in any inpatient, outpatient, ambulatory care or emergency department area of the Hartford Hospital campus. Department-specific guidelines for procedural sedation/analgesia do not invalidate nor revoke this general hospital-wide policy. PERSONNEL: 1. Licensed practitioners (M.D., D.O., D.M.D., D.D.S., A.P.R.N., P.A., R.N.) with appropriate privileges and who have successfully demonstrated adequate knowledge, skills, and competency in the administration of procedural sedation and analgesia. 2. Qualifications for administering procedural sedation/analgesia are listed in the Appendix I DEFINITIONS: Because levels of sedation are a continuum, it is not always possible to predict how an individual patient receiving medication with the intent to achieve sedation/analgesia for a procedure will respond. Definitions of the four levels of sedation and anesthesia include the following: Minimal sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and
CLINICAL PRACTICE POLICY PAGE: 2 OF 6 cardiovascular functions are unaffected. Moderate sedation/analgesia is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway. Spontaneous ventilation is adequate. Cardiovascular function is maintained. No additional cardio-respiratory support is required. Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway. Spontaneous ventilation may become inadequate. Cardiovascular function may be affected. General Anesthesia is a state of drug-induced depression of consciousness during which patients do not respond to stimulation, including painful stimulation, and consists of inhalation, IM, IV, spinal or major regional anesthesia. It does not include local anesthesia. The ability to spontaneously maintain ventilatory function is impaired and patients often require assistance in maintaining a patent airway. Positive pressure ventilation may be required because of decreased spontaneous ventilation or druginduced depression of neuromuscular function. Cardiovascular function may be impaired. Rescue Capacity: Personnel providing procedural sedation must ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended. Rescue from a deeper level of sedation may require interventions by a practitioner skilled in airway management and resuscitation to correct adverse physiologic consequences of the deeper-than-intended level of sedation and return the patient to the originally intended level of sedation. STAFFING: Sufficient numbers of qualified personnel (in addition to the practitioner performing the procedure) must be present during procedural sedation/analgesia to ensure the following : 1. Pre-procedural evaluation of the patient 2. Administration of sedative/analgesic medications 3. Performance of the procedure 4. Monitoring of the patient 5. Rescue of the patient in cases of unintended levels of sedation. 6. Recovery of the patient from sedation and discharge from post anesthesia recovery area 7. Facility requirements for equipment and monitoring are listed in Appendix II. A minimum of one additional person certified in Advanced Cardiac Life Support (ACLS) or departmental equivalent, should be available in close proximity during all procedures to assist in resuscitative efforts if necessary.
CLINICAL PRACTICE POLICY PAGE: 3 OF 6 For procedures requiring deep sedation, the physician administering medications and monitoring the patient cannot be the same physician performing the procedure. DOCUMENTATION: The following documentation must be completed. 1. Pre-procedural documentation should include: a. History and physical: i. Baseline vital signs ii. Airway assessment iii. Physical status classification b. Co-existing disease processes c. Laboratory evaluation as indicated d. Intravenous access (catheter gauge and location) e. NPO status (Appendix III) 2. Intra-procedural documentation: a. Vital signs including blood pressure, heart rate, heart rhythm, respiratory rate, end-tidal carbon dioxide when used, oxygen saturation, and level of consciousness (RASS) are to be documented every five (5) minutes during the procedure. b. Fluids/Estimated Blood loss c. Oxygen administration d. Adverse events 3. Post-procedural Documentation: a. Vital signs including blood pressure, oxygen saturation, heart rate, level of consciousness, and heart rhythm should be documented every fifteen (15) minutes until the patient meets discharge criteria or returns to baseline (if not being discharged) b. Documentation of additional medications if necessary. c. Complications including but not limited to nausea, vomiting, hypotension, respiratory depression, hypertension. d. Supplemental oxygen use e. Documentation of pain score f. The following post-procedural instructions for outpatient procedures should be provided to caregiver: i. Primary or follow-up physician s contact number. ii. Level of activity permitted (such as not operating a motor vehicle, heavy machinery, or signing legal documents). iii. Course of action if complications should develop. iv. Follow-up care DISCHARGE CRITERIA: 1. A physician qualified to administer procedural sedation/analgesia is responsible for discharge
CLINICAL PRACTICE POLICY PAGE: 4 OF 6 from the recovery unit. Criteria for discharge should be based upon the Modified Aldrete Scale (or equivalent). 2. Sufficient time (two hours) should elapse after last administration of reversal agents. 3. Outpatients should be discharged to a responsible adult who will accompany the patient to their place of residence whenever possible. This individual should receive post-procedural instructions and report any complications. QUALITY ASSESSMENT PERFORMANCE IMPROVEMENT AND ADVERSE EVENT REPORTING: The purpose of this QAPI program is to reduce patient risk and improve quality of care for patients undergoing procedural sedation/analgesia. Sedation services policies and procedures will undergo periodic re-evaluation that includes analysis of adverse events, medication errors and other quality or safety indicators related not only to procedural sedation, but also to the administration of medications in clinical applications that the hospital has determined involve procedural sedation/analgesia. The physician involved in the administration of procedural sedation/analgesia is responsible for reporting adverse events in a timely manner. This information will remain confidential in order to encourage physician participation in the quality improvement program. Each service involved in procedural sedation/analgesia will participate in a departmental and/or institution-wide multidisciplinary quality assurance program which monitors procedural sedation and analgesia practice, tracks adverse events, ensures satisfactory documentation and compliance with protocols, and identifies opportunities for improvement. APPENDIX I 1. Qualifications of Practitioners Administering Moderate Sedation/Analgesia Practitioners utilizing moderate sedation/analgesia techniques for procedures must be credentialed through the Medical Staff Office and their respective Clinical Department. In order for practitioners to administer moderate procedural sedation/analgesia, the practitioner must have current privileges and demonstrate competency through successful completion of the Hospital s web based exam reviewing pharmacokinetics, pharmacodynamics, indications, contraindications, doses, complications, and treatment of adverse reactions of drugs used for procedural sedation/analgesia. Licensed Practitioner's who order, administer, or monitor moderate sedation/analgesia will have and maintain current practice appropriate ACLS (Advanced Cardiac Life Support), ATLS (Adult Trauma Life Support), PALS (Pediatric Advanced Life Support), or NRP (Neonatal Resuscitation Program} certification or equivalent Departmental validation, prior to performing moderate sedation.
CLINICAL PRACTICE POLICY PAGE: 5 OF 6 Senior residents who utilize moderate sedation techniques must do so within their individual scope of practice, and have and maintain current practice appropriate ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), or NRP (Neonatal Resuscitation Program) certification and satisfactorily complete the airway rescue simulation course, prior to performing moderate sedation/analgesia. The Registered Nurse administering moderate sedation shall be trained in professional standards and techniques to safely administer pharmacologic agents to predictably achieve desired levels of sedation and monitor patients carefully in order to maintain the desired level of sedation. RN staff who administer and/or monitor sedated patients will complete the Moderate Sedation/Analgesia Competency Test prior to performing moderate sedation duties and at least annually thereafter. Inservice education and competency records will be maintained. Nursing Clinical Education staff in collaboration with the Department of Anesthesiology, will provide in-service education and training to nursing staff involved in the treatment, administration, and monitoring of moderate sedation. 2. Qualifications for Physicians Administering Deep Sedation/General Anesthesia A. Must have all Qualifications for Practitioners Administering Moderate Sedation/Analgesia plus B. Must be Board Certified in a physician specialty whose national organization has established guidelines for deep sedation/general anesthesia. These include but are not limited to: Anesthesiology, Emergency Medicine, Oral MaxilloFacial Surgery, and Dentistry. Appendix II Facility Requirement (Equipment and Monitoring) 1. Age appropriate emergency equipment and drugs should be available whenever procedural sedation/analgesia is administered as outlined below. 2. Appropriate monitors for procedural sedation/analgesia must include pulse oximeter, electrocardiogram and non-invasive blood pressure. Capnograph can be used when procedure allows. Temperature monitoring should be considered for pediatric patients and for procedures longer than one hour. 3. Intravenous access should be established in all patients receiving procedural sedation/analgesia regardless of the route of drug administration. 4. Availability of Basic Airway management equipment: a. Oxygen source (pipeline or tank with regulator), b. Face mask or nasal cannula
CLINICAL PRACTICE POLICY PAGE: 6 OF 6 c. Oral and nasal airways d. Positive pressure ventilation device (self-inflating breathing bag valve set) e. Suction source and catheters f. End-tidal carbon dioxide detector 5. Advanced Airway Equipment should be immediately available: a. Laryngeal mask airways b. Age appropriate laryngoscope and endotracheal tubes c. Stylet appropriately sized for endotracheal tubes 6. Emergency Equipment: a. Defibrillator should be immediately available b. Emergency drugs including pharmacological antagonists 7. Post -Procedural Recovery Area: a. Nurse to Patient ratio should not exceed 1:2 b. Monitors including electrocardiogram, pulse oximeter, non-invasive blood pressure and if indicated, temperature c. Oxygen source and suction must be available d. Basic airway equipment must be immediately available Appendix III Pre - Procedure Fasting Guidelines These recommendations apply to health ASA I and ASA II patients undergoing elective procedures. These guidelines do not guarantee complete gastric emptying. Ingested Material Minimal Fasting Period Clear liquids* 2 hours Breast milk 4 hours Infant formula 6 hours Non-human milk 6 hours Light meal (toast, clear liquids) 6-8 hours * Clear liquids include water, clear juices without pulp, clear carbonated beverages, black tea or coffee ISSUED: NOVEMBER 26, 2013 PROPONENT: DEPARTMENT OF ANESTHESIOLOGY DEPARTMENT OF EMERGENCY MEDICINE REPLACES: APPROVED BY: REVIEWED: REVISED: Monitoring, Support of Patients Receiving Moderate Sedation and Analgesia During Diagnostic, Therapeutic Procedures Policy, Revised Nov 2011 WABERSKI, SMALLY, MEISTERLING