POLICY MONITORING AND SUPPORT OF PATIENTS RECEIVING MODERATE SEDATION AND ANALGESIA DURING DIAGNOSTIC AND THERAPUTIC PROCEDURES POLICY A policy sets forth the guiding principles for a specified targeted population as such principles relate to specific clinical or operational issues. Page 1 of 8 Purpose: Scope: Policy: To provide guidelines for the administration of moderate sedation, with or without analgesia by non-anesthesia personnel, during diagnostic and therapeutic procedures where the loss of protective reflexes might occur and to define patient assessment, monitoring and documentation prior to, during and after procedures were moderate sedation is used. All patient care units and areas providing diagnostic and therapeutic services I. Definition Moderate or deep sedation and anesthesia are produced by pharmacologic agents such as sedatives and/or analgesics, plus general, spinal or other regional anesthesia, administered for any purpose, in any setting, by any route. A definition of the four levels of sedation and anesthesia include the following: Minimal sedation (anxiolysis) Anxiolysis is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Moderate sedation/analgesia ( conscious sedation ) Moderate sedation 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, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Deep sedation/analgesia Deep sedation is a drug-induced depression of consciousness during in which a patient cannot be easily aroused but will respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require
2 of 8 assistance maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Anesthesia Anesthesia consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia alone. General anesthesia is a drug-induced loss of consciousness during which patients cannot be aroused, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or druginduced depression of neuromuscular function. Cardiovascular function may be impaired. A variety of factors, including medication and its dosage, the patient s ability to metabolize or eliminate medication, the patient s sensitivity to drug effect or the type or duration of procedure may affect the level of sedation, analgesia or anesthesia attained. Because sedation-to-anesthesia is a continuum, it is not always possible to predict how an individual patient will respond when given medication intended to achieve moderate sedation and analgesia. Therefore, qualified individuals who administer pharmacologic agents intended to achieve a predictable, desired level of sedation must closely monitor patients in order to maintain them at the desired level of sedation. Individuals administering moderate or deep sedation and analgesia are qualified and appropriately credentialed to manage patients at whatever level of sedation or analgesia is achieved, either intentionally or unintentionally. The qualifications of individuals providing moderate sedation and analgesia for a diagnostic or therapeutic procedures are competency-based education, training and experience. The competencies include: 1. Evaluation of patients prior to performing the procedure 2. Rescue of patients who unavoidably or unintentionally slip into a deeper than desired level of sedation/analgesia 3. Management of an unstable cardiovascular system 4. Management of a compromised airway by providing adequate oxygenation and ventilation Competency assessment shall be the responsibility of each discipline.
3 of 8 II. Personnel, Training and Credentialing A minimum of two personnel must be present during the procedure; one individual performing the procedure and one assistant who monitors and records appropriate physiologic variables. Privilege to include sedation procedures within the scope of practice for a physician, dentist who is licensed by the State of Connecticut to administer intravenous sedation, or licensed independent practitioner (LIP) is obtained in two ways: completion of a Sedation Self-Assessment Test or provision of ten (10) cases for review as required by the Chief of the physician or LIP s section. Nursing staff and other personnel who monitor patients who receive moderate sedation/analgesia during procedures complete competency evaluation administered by the individual s department, followed by annual validation. The assistant shall be CPR validated and trained in the monitoring of respiratory and cardiovascular status, including pulse oximetry. At least one person present during the procedure shall be trained in airway management including positioning of the airway, use of oropharyngeal and nasopharyngeal airways, and the application of positive-pressure ventilation by bag and mask. At least one person shall be with the patient from the time of administration of the sedation until recovery is judged adequate or the patient is transferred to personnel performing recovery care. III. Equipment/Monitoring 1. Intravenous (IV) Access It may be necessary to initiate sedation via alternate routes before IV access can be obtained. If adequate sedation/analgesia is obtained by nonintravenous routes, IV access must be pursued as a conduit to fluid and medication administration for patient resuscitation. For outpatient procedures, IV access shall be maintained until the Aldrete score returns to baseline. 2. Oxygen Delivery System The following choices must be available and one must be in use at all times. Primary oxygen source from wall or cylinder with emergency back up of one cylinder Self-inflating positive pressure oxygen delivery system with bag and masks appropriate for the patient population being treated Nasal tubing and/or facemasks for delivery of oxygen during the procedure
4 of 8 3. Pulse oximeter A pulse oximeter must be used at all times. 4. Blood pressure monitoring device A blood pressure monitoring device, either manual or automatic, must be used at all times. 5. Cardiac Monitor Continuous cardiac monitoring is required. 6. Suction Suction from wall or portable source must be immediately available. 7. Emergency cart Emergency cart must be readily available, along with reversal agents. IV. Hospital-wide Sedation/Analgesia Flowsheet A moderate sedation/analgesia flowsheet (Form #HH571606) must be used for procedures requiring moderate sedation/analgesia. Its use provides assurance that the standard of care is applied universally throughout the institution. Therefore, it is important that the flowsheet be completed in its entirety each time it is used. It is permissible to write see medical record on the flowsheet as appropriate to avoid duplicate charting. V. Baseline Evaluation and Preparation The following shall be documented on the Sedation Flowsheet: 1. Diagnosis and planned procedure A pre-sedation evaluation of the patient is to be performed by a physician or otherwise qualified licensed independent practitioner (LIP) prior to beginning the procedure. Based on the evaluation, a plan for sedation/analgesia is selected and documented. 2. Consent Discussion by the physician with the patient, or their legal representative, about the procedure and its sedation/analgesia must occur prior to the procedure. Consent to the procedure and its sedation/analgesia is evidenced by an Authorization for Surgery and/or Special Procedure/Treatment form signed by the patient and the physician. 3. Patient History, including
5 of 8 Medications Allergies Past Medical, Surgical, Anesthesia and Sedation history Review of Systems Psychosocial history 4. Risk Assessment (ASA Class) The ASA classification is based on the American Society of Anesthesiologist s Physical Status Category Class I, a normal healthy patient with no systemic disease Class II, a patient with mild to moderate systemic disease such as diabetes or hypertension Class III, a patient with severe systemic disturbance or disease with a functional limitation that is not incapacitating such as active cardiac, pulmonary or renal disease Class IV, a patient with severe systemic disturbance or disease that is incapacitating and life threatening, such as COPD with respiratory failure, or active UGI bleeding Class V, a moribund patient who has little chance of survival but is undergoing an operation in desperation An E shall be added to the Class to signify an emergency case VI. Immediate pre-procedure evaluation Immediately before the administration of sedation/analgesia, the patient is to be re-assessed by a physician or licensed independent practitioner (LIP). The notation shall include changes in medical condition or NPO status. The patient shall be queried as to acute pain, utilizing the 0-10 scale, and the response noted. The time of last oral intake shall be recorded. SOLIDS AND NON-LIQUIDS CLEAR LIQUIDS Adults 6 hours 2-3 hours Children > 6 months 6 hours 2-3 hours Children < 6 months 6 hours 2 hours
6 of 8 Using the Aldrete scoring system, an assessment of vital signs, level of consciousness, skin color and muscle function is performed at this time. A pre-procedure Aldrete score shall be documented to assist in establishing the patient s baseline. Aldrete Scoring System Points Moves 4 extremities voluntarily or on command Moves 2 extremities voluntarily or on command Moves 0 extremities voluntarily or on command Able to deep breathe or cough freely Dyspnea or limited breathing Apnea BP +/- 20mmHg of baseline BP +/- 21-40 mmhg of baseline BP +/- 41mmHg of baseline Fully awake Arousable on calling Not responding Pink Pale, dusky, jaundice or other Cyanotic Total Points (Maximum = 10) Preprocedure Postprocedure At discharge from outpatient procedure VII. Final Verbal Confirmation Immediately prior to the administration of medication, there shall be a time-out taken where the physician shall verbally confirm the patient s identity, the procedure and procedure site with the other team members using supporting documentation. VIII. Intra-Procedure Blood pressure, heart rate, respiratory rate, level of consciousness and oxygen saturation shall be documented on the sedation flowsheet no less frequently than every ten (10) minutes throughout the procedure. Medications, including route, time and dose shall be documented.
7 of 8 Oxygen therapy in L/min and means of delivery (nasal prongs, mask) shall be documented. IX. Post-Procedure Recovery Period The post-procedure period begins immediately after the procedure is completed. There are three (3) phases of recovery from sedation/analgesia: Phase I: The patient exhibits residual effects of sedation/analgesia. There may be some alteration in vital signs or level of consciousness Phase II: The patient is stable and has returned to pre-sedation Aldrete score or a baseline acceptable to medical staff. Phase III: The patient s pain is under control and s/he is able to tolerate oral fluids. The patient is ready for discharge from the hospital. During the immediate post-procedure period, an ongoing assessment of vital signs, level of consciousness and oxygenation saturation shall be noted on the flowsheet every 15 minutes x 2, then every 30 minutes until the patient has returned to pre-sedation status via a repeat Aldrete score. Notify the physician and anticipate the potential need for use of reversal agents, medications and other resuscitative interventions. The post- Aldrete score is obtained with the first timed post-procedure assessment done at fifteen (15) minutes, including a reassessment of vital signs, level of consciousness, skin color and return to baseline of muscle function such that the patient can ambulate, if appropriate, or be maintained at bedrest if indicated. An inpatient may be considered recovered from the sedation/analgesia on attaining Phase II Recovery. It is at this time that they may be returned, if appropriate, to their pre-sedation/pre-procedure level of care. A third Aldrete score is documented to confirm that the patient has recovered from the sedation/analgesia. Staff are responsible for reviewing and carrying out post-procedure orders for any additional post-procedure monitoring requirements that may extend past the patient s return to baseline from the moderate sedation/analgesia. During the post-procedure period, the patient shall again be queried as to acute pain, utilizing the 0-10 scale, and the response noted. Outpatients may be discharged on progressing through and completing Phase I and II of recovery and attaining Phase III. A physician or qualified licensed independent practitioner can discharge an outpatient
8 of 8 from the hospital or an inpatient to a patient care unit from a post-sedation area. A registered nurse may discharge patients via written criteria approved by the medical staff. If an outpatient procedure is performed, the third Aldrete score shall be performed at the time of discharge from the hospital to reconfirm the decision to discharge. If the third Aldrete score does not return to baseline, a physician or licensed independent practitioner must be notified. The notification, discussion of the clinical situation and the outcome shall be documented on the sedation/analgesia flowsheet. An outpatient shall receive written post-procedure instructions and be queried to ensure that s/he has adequate pain relief prior to discharge in the company of a responsible adult. These activities shall be documented on the sedation flowsheet. A telephone or verbal report of the status of an inpatient shall be made to the receiving unit and documented on the sedation flowsheet before the patient is transferred to further care within the hospital. Key search terms: moderate sedation, conscious sedation, moderate sedation/analgesia, moderate sedation and analgesia, sedation, Aldrete, Aldrete score Issued: May 1996 Proponent: Vice President of Medical Affairs Replaces: Conscious Sedation Protocol, June 1994 Approved By: Review Date October 2008 Revised Date: October 2006 Medical Executive Committee, Healthcare Team Policy and Procedure Committee