Procedural Sedation. Purpose. Applicability. Principles. Policy Elements

Transcription

1 Approved by: Vice President & Chief Medical Officer; and Vice President & Chief Operating Officer Procedural Sedation Corporate Policy & Procedures Manual Number: VII-B-430 Date Approved July 14, 2016 Next Review (3 years from Effective Date) January 2021 Purpose Applicability To enhance the safety of all patients receiving procedural sedation within Covenant Health, and to facilitate the assessment and monitoring of all patients undergoing procedural sedation by competent health care professionals within safe clinical environments. This policy and procedure applies to health care professionals who prescribe, administer and/or monitor patients who receive procedural sedation medications. This policy does not apply to patients less than 15 years of age, anesthesiologists administering sedation in the operating room, patients in a critical care or palliative care setting. Principles The agents employed in procedural sedation are potent medications that attenuate not only awareness and recall, but also ventilation and cardiac performance in ways that may be life-threatening. While these medications in most patients behave in a predictable, albeit rapid and profound manner, they may produce abrupt apnea and cardiac decompensation that may not be predicted in some patients, It should be recognized that the practice of sedation is evolving and that the standards and requirements articulated in this policy will also evolve over time to keep pace with those standards. Policy Elements 1. Informed Consent for Treatment 1.1 The most responsible health practitioner is responsible for informing the patient of the risks of receiving procedural sedation. Informed consent may be expressed verbally or in writing, or be implied. Refer to Covenant Health Consent to Treatment policy and procedures for details and exceptions in the case of emergency situations. 2. Professional Responsibility 2.1 Health care professionals performing procedural sedation will have the knowledge and advanced specialized skills to safely administer procedural sedation medications and be able to perform bag mask ventilation and other emergency interventions if required. 2.2 Prior to ordering and/or administration of procedural sedation, the health care professional shall determine what backup assistance needs to be in place (i.e. anaesthetic back-up or nursing/respiratory/paramedic assistance). Patient risk factors include, but are not limited to, patients

2 VII-B-430 Page 2 of 15 who are morbidly obese, have COPD or swallowing difficulties, high blood pressure, who are elderly, frail, or chronic narcotic users, etc. 2.3 Propofol should only be prescribed and administered in the presence of a health care professional who has been trained in intubation. This is due to less predictable outcomes and no reversal available. 2.4 The ability to evaluate the cardiovascular, respiratory and neurological reserve of the patient, especially as they relate to the pharmacologic effects of the medications employed, is a necessary precondition to obtaining and maintaining competency for sedation. 3. Ordering Procedural Sedation 3.1 Procedural sedation will only be prescribed by authorized health care professionals who have been; trained and are competent in procedural sedation and the pharmacology related to sedative, anxiolytic, analgesic and reversal agent medications; and sanctioned by Covenant Health Medical Staff Bylaws and/or standards/expectations established in Covenant Health. 3.2 Prior to the administration of the initial dose of procedural sedation, the authorized prescriber shall provide a written order which stipulates drug, dose, route, and the targeted level of sedation to be employed for this procedure. (See Appendix A, Levels of Sedation and Anesthesia.) a) For Emergency Medical Services, assure that initiating the use of procedural sedation conforms to the conditions of use of the Alberta Health Services' Emergency Medical Services Medical Control Protocols. 3.3 Sedative, dissociative, anxiolytic, analgesic and reversal agents employed during or immediately after procedural sedation, via all routes of administration, can only be ordered by the following authorized prescribers as defined within their scope of practice: a) physicians, b) dentists, c) oral surgeons, d) podiatrists, e) nurse practitioners, f) midwives, and g) EMS. 4. Assessment Prior to the Administration of Procedural Sedation 4.1 Prior to the administration of procedural sedation, a baseline assessment must be undertaken as outlined in Procedure point #1.5. The patient's

3 VII-B-430 Page 3 of 15 baseline assessment will be documented in the patient's health record, by the health care professional undertaking the baseline assessment. 5. Administering Medications 5.1 In the event that the sedating agents are to be administered by a nonintravenous route (eg. rectally, orally, intramuscularly or intranasally), the most responsible health practitioner shall assess and, where indicated for safety, shall ensure that the patient has patent intravenous access prior to the procedure. 5.2 Intravenous procedural sedation medications can only be administered in the presence of a physician, dentist, oral surgeon, podiatrist, nurse practitioner, midwife, or paramedic operating under approved protocols, and who is competent in procedural sedation and procedural sedation pharmacology, resuscitation and airway management. a) Administration is limited to health care professionals who have achieved the required learning at prescribed intervals in procedural sedation and procedural sedation pharmacology, cardiopulmonary resuscitation and airway management, and who are authorized to perform this procedure per their regulatory College. 5.3 Procedural sedation beyond anxiolysis will only be undertaken by competent health care professionals who can provide the required intraprocedure care and monitoring as outlined in the Procedure section. 6. Intra-Procedure and Post-Procedure Monitoring 6.1 Programs undertaking procedural sedation within Covenant Health will secure, replenish and maintain all appropriate monitoring and emergency equipment as defined in the Procedure section. 6.2 If required, ensure a second health care professional competent in patient monitoring is present in the room with the patient (see section 3.2 in Procedure). 6.3 All monitoring and emergency equipment will be functional. All emergency equipment and medications (including antagonist medications) will be present prior to the commencement of the administration of procedural sedation. 6.4 All health care professionals providing care for patients undergoing procedural sedation will be trained and competent using monitoring and emergency equipment. Monitoring of patients undergoing procedural sedation will be undertaken in accordance with Appendix B, Health Care Provider and Monitoring Frequency Requirement.

4 VII-B-430 Page 4 of All assessment data, including vital signs, medications used in sedation, and the patient's response to the procedure and sedation, will be recorded in the patient's health record and acted upon as necessary. 7. Recovery and Discharge of Patients Following Procedural Sedation 7.1 All patients receiving procedural sedation must meet the discharge criteria prior to discharge (see section 4 of the procedure). It is recognized that Emergency Medical Services providers will transfer care to an Emergency Department whenever sedation is employed to perform a procedure. 7.2 Any patient that does not reach the desired level of recovery, as determined by the authorized prescriber, no matter how measured, and/or the patient's baseline level of assessment, or has experienced any complications during the treatment / procedure, must be monitored postprocedure in an appropriate clinical area. 7.3 The authorized prescriber who ordered the procedural sedation shall: a) maintain responsibility of care of the patient until the patient is fully recovered and discharged home, or until care for the patient is accepted by another physician / most responsible health practitioner; and b) be able to respond both verbally and in person when requested for assistance by another health care professional. This response should be as rapid as possible, be consistent with the nature of the condition triggering the request and reflect professional standards of care. 7.4 Patients administered a benzodiazepine or opioid reversal agent must be monitored for a minimum of two hours after the administration of said reversal agent to ensure the patient does not become re-sedated after reversal effects have worn off. 7.5 The authorized prescriber will contact and consult with an emergency physician and/or an anesthesiologist as soon as possible regarding any patient in a community-based clinic who does not meet the discharge criteria post-procedural sedation, and who can no longer be managed in the community setting. 7.6 Health care professionals shall advise patients that following the administration of procedural sedation they should be accompanied by a responsible adult at the time of discharge from the facility, if at all possible. If the patient chooses to leave without being accompanied, or does not have this support available to them, document this information in the patient's health record If the patient insists on leaving unaccompanied and/or does not have support available to them, then this shall be documented in the patient's health record.

5 VII-B-430 Page 5 of Fitness for discharge should not be confused with a patient's capacity to consent to or to engage in important decisions or behaviours related to life, limb and finances. Advise patients per section 4.3) of the procedure. 8. Transfer of Patients Following Procedural Sedation 8.1 Prior to any transfer of patients to alternate clinical areas or sites, the most responsible health practitioner must determine whether the transfer is necessary or appropriate. 8.2 Section (5) of the Procedure will be followed when determining the level of heath care professional support required for patients being transferred / transported following the administration of procedural sedation. 8.3 Sedation beyond anxiolysis shall not be administered immediately prior to transfer between departments or sites unless ordered by the authorized prescriber. 9. Documentation 9.1 Documentation of assessments, administration of medications, monitoring, transportation, and discharge - prior to, during and following the administration of procedural sedation - must be recorded in the patient's health record. Procedure 1. Procedural Sedation Pre-Procedure Requirements 1.1 Confirm informed consent has been obtained for the procedure. 1.2 Verify authorized prescriber order ensuring the drug, initial dose range and route are stipulated. 1.3 Identify the intended target level of sedation and communicate it clearly to all involved staff. (See appendix A, Levels of Sedation and Anesthesia.) 1.4 Once the initial dose of procedural sedation has been administered, subsequent orders for sedating medication may be given verbally, repeated back to the authorized prescriber for confirmation, then administered. Refer to Covenant Health policy #VII-B-125, Medication Orders for requirements of verbal orders. a) For Emergency Medical Services, ensure that initiating the use of procedural sedation conforms to the conditions of use of the Alberta Health Services Emergency Medical Services Medical Control Protocols. 1.5 Prior to administering the medication, where practical (i.e. the situation is not an emergency where the life or safety of the patient, or of health care

6 VII-B-430 Page 6 of 15 providers, may be jeopardized by complying) and in order of priority, do the following: a) Document patient weight and current medication in patient health record; b) Check for history of allergies and previous adverse reactions to sedatives, narcotics (opiods) or general anesthesia. Document on Caution Record per Corporate Policy #VII-B-360, Allergy and Adverse Drug Reaction - Documentation and Communication. c) Ensure patient medical history and clinical exam, including (when possible) an airway assessment, are completed and documented in the patient health record by the prescribed prescriber; d) If the pre-sedation patient assessment identifies serious or multi risk factors then the appropriate measures (i.e. extra staff, anesthetic consult, prolonged recovery monitoring, etc.) are arranged pre-sedation; e) Assess/ask if any narcotics (opioids), respiratory depressants or medications with central nervous system depressing effects (including over-the-counter, anti-seizure or illicit drugs) were given/taken within the last 12 hours; f) Perform a baseline assessment and document in the patient health record. The parameters for the baseline assessment include; level of consciousness heart rate blood pressure, and oxygen saturation g) Ensure an authorized prescriber to order procedural sedation medication is present or immediately available; h) Verify time and type of last intake of food or drink and document in patient health record; i) Ensure appropriate emergency medications, including appropriate antagonist medications, are readily available; j) Ensure appropriate monitoring equipment is readily available, set up and operational (see Section 1.4 of this document and Appendix C, Procedural Sedation Monitoring and Response Requirements); and k) Ensure intravenous access is patent or equipment for intravenous access is present. 1.6 If the clinical area is not covered by a code blue team or a rapid response team, a fully stocked cardiac resuscitation cart should be readily available.

7 VII-B-430 Page 7 of 15 (See the College of Physicians and Surgeons of Alberta Non-Hospital Surgical Facility Standards and Guidelines for more details.) The cart must include: a) A cardiac monitor with defibrillator and backboard for cardiopulmonary resuscitation (CPR); b) Endotracheal tubes, stylets, Magill forceps, an array of extraglottic devices (LMA) or endotracheal tubes (ETT) to accommodate the adult population; and c) Two functioning laryngoscopes, a variety of sizes of laryngoscope blades and endotracheal tubes. 2. Special Considerations 2.1 The authorized prescriber may wish to consult with an Obstetrician after 24 weeks gestation for patients receiving procedural sedation for a nonobstetrical-related event, with particular emphasis on fetal monitoring and movement during and after any treatment/procedure, and resource requirements/location for same. 2.2 The authorized prescriber may wish to consult with a Lactation Consultant for analgesia or sedative use advice for breastfeeding patients. a) Analgesia/sedation for breastfeeding patients depends on numerous factors, notably the health and physiological development of the infant. b) The recommendation for Lactation Consultant advice in this section is contingent on accessibility and availability for any site. If a Lactation Consultant is not available, call the Anesthesiologist or Obstetrician on-call for direction. 3. Intra-Procedure and Post-Procedure Monitoring Requirements 3.1 Refer to Appendix B, Health Care Provider and Monitoring Frequency Requirement. 3.2 Monitor the following: a) vital signs (blood pressure, and heart rate); b) oxygen saturation; c) end tidal dioxide (ETCO 2 - capnometry or capnography) if available d) level of consciousness, responsiveness; and e) general status.

8 VII-B-430 Page 8 of Electrocardiogram monitoring is not required for all patients though strongly advised in patients where underlying cardiopulmonary disease (eg. previous myocardial infarction or dysrthymias) may impact the patient outcomes during or post procedure. 3.4 The patient's vital signs and clinical responses should be monitored/ observed closely at all times. Document all assessment data, including vital signs, medication used in sedation and the patient's response to both the procedure and sedation in the patient health record, at the time the assessment takes place as outlined on Appendix C, "Health Care Provider and Monitoring Frequency Requirement'. 3.5 Complete and document recovery from sedation post-procedure in the patient health record using the Aldrete Recovery Score (see Appendix D). 4. Recovery and Discharge of Patients Following Procedural Sedation 4.1 Discharge only if the patient meets the following criteria prior to discharge and has returned to a physical and mental status that is comparable to his/her pre-sedation condition. a) Aldrete Recovery Scores of eight or greater are considered adequate for discharge. b) Any patient that does not reach an Aldrete Recovery Score of eight or greater and/or the patient's baseline level of assessment, or has experienced any complications during the treatment/procedure, must be monitored post-procedure in an appropriate clinical area. c) No matter the scale used, documentation in the patient's health record following procedural sedation is required. 4.2 For an outpatient discharged home, the patient will, if at all possible, be accompanied by a family member/caregiver who is able to care for the patient, with instructions and contact information for whom to report any post-procedural complications. If the patient chooses to leave without being accompanied, or does not have this support available to them, document this information in the patient's health record. 4.3 Along with any other discharge materials and instructions (verbal and written) given, caution patients strongly against engaging in major decision-making or driving, operating heavy machinery, or engaging in similarly hazardous activities for a minimum of eight hours post-sedation or a period of time described by the authorized prescriber's orders. 4.4 Advise patients diagnosed with obstructive sleep apnea (OSA), and treated with any form of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), to employ their devices in any setting where they may fall asleep for a period of 24 hours post-discharge.

9 VII-B-430 Page 9 of Transfer of Patients Following Procedural Sedation 5.1 The authorized prescriber may authorize the transfer of a patient who has received procedural sedation to an alternate clinical area or site if it is deemed necessary or appropriate. 5.2 The patient's Aldrete Recovery Score must be assessed, acted upon, and recorded in the patient's health record prior to transfer to an alternate clinical area or site. 5.3 Patients with an Aldrete Recovery Score of less than eight following procedural sedation, shall: a) only be transported/transferred post-procedure, if it is deemed necessary and authorized by the authorized prescriber; and b) only be transported/transferred if the patient is accompanied by a health care professional competent to both monitor the patient and provide care in an emergency situation during transfer. NOTE: The health care professional accompanying the patient must remain with the patient until the receiving area accepts care of the patient. 5.4 Sedation beyond anxiolysis shall not be administered immediately prior to transfer between departments or sites unless authorized by the authorized prescriber. a) If such approval from the authorized prescriber is obtained, the patient must be accompanied by a health care professional competent to monitor the patient and to provide care in an emergency situation. 6. Documentation 6.1 Documentation of assessments; administration of medications, monitoring, transportation, and discharge - prior to, during and following the administration of procedural sedation - must be recorded on the patient's health record. 6.2 Confirmation of the patient's planned post-procedure transportation shall be documented in the patient's health record. 6.3 Discharge instructions shall be documented in the patient's health record and reviewed with the patient, family member and/or the patient's caregiver/alternate decision-maker, prior to the patient's discharge. 6.4 Adverse events, close calls and hazards shall immediately be reported as outlined corporate policy #III-45, Responding to Adverse Events, Close Calls and Hazards.

10 VII-B-430 Page 10 of 15 Definitions Adverse event means an event that could or does result in unintended injury or complications arising from health care management, with outcomes that may range from death or disability to dissatisfaction, or require a change in care (such as prolongation of hospital stay). Alternate decision maker means a person who is authorized to make decisions with or on behalf of the patient. These may include specific decision-maker, a minor's legal representative, a guardian, a 'nearest relative' in accordance with the Mental Health Act or an agent in accordance with a Personal Directive or a person designated in accordance with the Human Tissue and Organ Donation Act. Anxiolysis means a medication-induced state during which patients respond normally to verbal commands, although cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected. Authorized prescriber means a health care professional who is permitted to prescribe medications as defined by Federal and Provincial legislation, her/his regulatory college, Covenant Health, and practice setting (where applicable). Close call means an event in which a patient is exposed to or involved in a situation with the potential for harm. For one or more reasons the danger did not reach the patient (that is, no harm occurred). Competent means a health care professional who possesses the knowledge, skills, attitudes and judgement required to safely perform professional health services. Health care professional means an individual who is a member of a regulated health discipline, as defined by the Health Disciplines Act or the Health Professions Act, and who practices within scope or role. Health record means the Covenant Health legal record of the patient's diagnostic treatment and care information. Informed consent means the agreement of a patient to undergo a treatment/procedure after being provided with the relevant information about the treatment/procedure(s), its risks and alternatives and the consequences of refusal. Most responsible health practitioner means the health professional who has responsibility and accountability for the specific treatment/procedure(s) provided to a patient and who is authorized by Covenant Health to perform the duties required to fulfill the delivery of such a treatment/procedure(s) within the scope of his/her practice. Procedural sedation means the administration of sedatives/anxiolytics/analgesics via the oral, intranasal, inhaled, intravenous, intramuscular, rectal or sublingual route, for the purposes of assisting patients in their ability to tolerate unpleasant diagnostic or therapeutic treatment/procedure(s). Treatment/procedure(s) means a specific treatment, investigative procedure(s), or series of treatment/procedure(s) planned to manage a clinical condition.

11 VII-B-430 Page 11 of 15 Verbal Order is a medication order given by the prescriber to a qualified staff in emergency /urgent situations where the prescriber is unable to document the medication order themselves. A verbal order is given face to face. Related Documents & Resources Procedural Sedation Guidelines for Rural Physicians (available through the Physician Portal on compassionnet) Appendices: A - Levels of Sedation and Anesthesia B - Health Care Provider and Monitoring Frequency Requirement C - Procedural Sedation Monitoring and Response Requirements D - The Aldrete Score Covenant Health Policies / Procedures VII-B-60, Consent to Treatment/Procedure(s) - Adults with Impaired Capacity who Lack Capacity III-40, Disclosure of Adverse Events, Close Calls and Hazards III-45, Responding to Adverse Events, Close Calls and Hazards VII-B-125, Medication Orders Procedural Sedation Record form #CV-0590 ( ) Procedural Sedation Checklist Procedural Sedation Educational Materials - available on CLiC References Alberta Health Services Procedural Sedation Policy & Procedure, Level 1 (effective June 16, 2014). Alberta Health Services, Procedural Sedation Education Materials accessed June 26, 2014 Chronological Revision Date(s) June 1, 2016

12 VII-B-430 Page 12 of 15 Levels of Sedation and Anesthesia Appendix A RESPONSIVENESS AIRWAY BREATHING CIRCULATION 1. Minimal or Light Sedation Normal response to verbal stimulation May impair cognitive function and coordination Anxiety Maintained Adequate Maintained 2. Moderate Sedation / Analgesia = Procedural Sedation Responds purposefully to verbal or tactile stimulation Amnesia may be present Potential loss of protective reflexes Maintained Adequate Maintained 3. Dissociative Sedation - trance-like cataleptic state induced by ketamine Characterized by profound Maintained Maintained Maintained analgesia and amnesia 4. Deep Sedation / Analgesia Not easily aroused, but responds purposefully* to repeated or painful stimulation May require assistance to maintain patent airway. Spontaneous ventilation may be impaired or inadequate Usually maintained 5. General Anesthesia Unarousable even with painful stimuli Loss of verbal/physical command Loss of spontaneous movement Total loss of protective reflexes Requires assistance to maintain patent airway Impaired ability to maintain respiratory function * Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. May impair cardiovascular function Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Individuals administering moderate sedation / analgesic ("conscious sedation") should be able to rescue patients who enter a state of deep sedation / analgesic, while those administering deep sedation / analgesia should be able to rescue patients who enter a state of general anesthesia. Rescue of a patient from a deeper level of sedation than intended is an intervention by a practitioner proficient in airway management and advanced life support. The qualified practitioner corrects adverse physiologic consequences of the deeper-than-intended level of sedation (such as hypoventilation, hypoxia and hypotension) and returns the patient to the originally intended level of sedation. It is not appropriate to continue the procedure at an unintended level of sedation if the patient is unstable.

13 VII-B-430 Page 13 of 15 Appendix B Health Care Provider and Monitoring Frequency Requirement Intra-procedural health care providers Intra-Procedural Monitoring Frequency & Documentation Post Procedural Health Care Providers and Monitoring Frequency & Documentation Minimal Sedation Anxiolysis Minimum one health care provider. Medication documentation is completed Vital signs may be required dependent on the patient's condition Medication documentation is completed Vital signs may be required dependent on the patient's condition Moderate Sedation / Dissociative Sedation Minimum two health care providers. one to perform the procedure and order medication one to assist the proceduralist, monitor the patient, and administer medication as needed Place patient on continuous oximetry Observe/monitor the patient at all times. Document vital signs at the time of assessment or every 15 minutes as a minimum standard throughout the procedure and immediately following procedure Monitor and document vital signs every 15 minutes for at least 30 minutes and until the patient reaches Aldrete Score of 8 or returns to baseline level of assessment Deep Sedation Minimum three health care providers: one to perform the procedure and order medication one dedicated to assisting with procedure one dedicated to monitoring patient and administration of medication (must be competent to administer medication by IV injection and must not be assisting with procedure) Place patient on continuous oximetry Monitor and document vital signs every 5 minutes throughout the procedure and immediately following procedure Capnography (by Dec. 31, 2016) Monitor and document vital signs every 15 minutes for at least 30 minutes and until the patient reaches Aldrete Score of 8 or returns to baseline level of assessment A patient who experiences an intra-procedure complication or requires a reversal agent must be monitored for a minimum of two hours post-procedure and achieve an appropriate Aldrete score prior to being discharged.

14 VII-B-430 Page 14 of 15 Appendix C Procedural Sedation Monitoring and Response Requirements Monitoring / Medical Equipment Emergency Equipment / Medications Cardiac monitoring and/or non-invasive blood pressure monitor and/or manual blood pressure cuff and stethoscope. Appropriate size airways and resuscitation bag and mask. Extraglottic devices (LMA) or endotracheal tubes (ETT). Pulse oximeter. Suction Oxygen administration equipment (connected and ready to administer oxygen) Medication to reverse the sedation must be readily available. IV supplies and accessory equipment such as syringes, needles. Crash cart or immediately available Code Blue team. End tidal carbon dioxide (ETCO 2 ) monitoring (as possible).

15 VII-B-430 Page 15 of 15 Appendix D The Aldrete Score Activity Able to move voluntarily or on command 4 extremities = 2 extremities = 0 extremities= Score Respiration Able to deep breathe and cough freely = Dyspnea or limited breathing = Apneic = Circulation BP + 20% of Pre-anesthetic level = BP % of Pre-anesthetic level = BP greater than or equal to 50% of Pre-anesthetic level = Consciousness Fully awake = Arousable on calling = Not responding = Colour Pink = Pale, dusky, blotchy, jaundiced, other = Cyanotic TOTAL SCORE Aldrete J.A., Kroulik D. Recovery Score. Anesthesia Analgesia. 1970;