Guidelines for the Care of Patients undergoing Moderate or Procedural Sedation The Medical City Good Hospital Practice Training Series 2009

Outline of presentation Policy statement and purpose Definitions, levels of sedation and anesthesia Qualifications and roles of physician and assistant Mandatory equipment Responsibilities Patient selection criteria Pre-, intra- and post-procedure assessment and care Discharge criteria Documentation and outcomes measurement

Policy Statement Sedation administered to inpatients and to outpatients shall be carried out to provide the best clinical conditions while performing a diagnostic, therapeutic or surgical procedures insuring that the patient’s well being is safeguarded at all times.

Purpose To establish appropriate guidelines for the safe use of medications that alters a patient’s state of consciousness. These guidelines apply to any setting, for any purpose, by any route, when a patient receives medication that alters their state of consciousness.

Definitions Procedural sedation/analgesia is the proper administration of drugs to obtund, dull, or reduce the intensity of pain or awareness. The administration of these drugs by any route carries the risk of loss of protective reflexes.

Levels of Sedation and Anesthesia  Minimal sedation (Anxiolysis) : 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.

Levels of Sedation and Anesthesia  Moderate sedation/ Analgesia (Conscious sedation): A drug-induced depression of consciousness during which the 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. -Cardiovasular function is usually maintained.

Levels of Sedation and Anesthesia  Deep Sedation/Analgesia: 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 and spontaneous ventilation may be inadequate. -Cardiovascular function is usually maintained.

Levels of Sedation and Anesthesia  Anesthesia: Refers to general anesthesia. -General Anesthesia is a drug-induced loss of consciousness during which patients are not arousable, 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 a drug-induced depression of neuromuscular function. -Cardiovascular function may be impaired.

Exclusion Moderate Sedation guidelines do not apply to the use of sedatives and/or narcotic agents when used for: Pain management Control of seizures Withdrawal syndromes when individual doses must be titrated to a disease specific response Sedated patients on a ventilator

Exclusion These moderate sedation guidelines apply to those procedures where moderate sedation is administered by non-anesthesiologists. The same standard of practice applies when moderate sedation is administered by anesthesiologists according to ASA standards.

Personnel Qualifications and Roles Physician: The physician must have Advanced Cardiac Life Support (ACLS) Certification and complete a course of instruction on sedative medication usage approved by the Chair of the Department of Anesthesiology. The role of the physician is: 1.to prescribe sedation 2.to assure the level of monitoring required in this policy 3.to manage complications of the sedation

Personnel Qualifications and Roles Physician: If a patient is deemed as having unusual airway problems or an ASA PS III or IV class patient, an anesthesiologist must be available to ensure adequate airway management and additional monitoring.

Personnel Qualifications and Roles Assistant: –An assistant who is BLS certified and has completed a course of instruction on sedative medication usage approved by the Chair of the Department of Anesthesiology shall be present. This assistant will be privileged for this specific function. –In the event that the assistant is a technician then a Registered Nurse (RN) must be readily available to supervise the assessment and monitoring of the patient.

Personnel Qualifications and Roles Assistant: –The role of the assistant is to monitor and record appropriate physiologic parameters and to assist in any supportive or resuscitative measures as required for sedated patients. –If a patient becomes deeply sedated then one person (MD, assistant or other) will stop all other duties and have the sole function of monitoring the patient’s status, ascertaining airway patency and ventilation, and documenting vital signs every 5 minutes.

Mandatory Equipment Immediate access to these equipment is required: –Cardiac monitor –Pulse oximeter –Medications for sedation and reversal of effect –Blood pressure unit –Oxygen source and administration equipment –Bag-valve-mask –Standard emergency equipment and drugs for resuscitation –Defibrillator –Suction Machine –Stethoscope

Responsibilities Chairman of the Department of Anesthesiology and designated Ad Hoc Team: a.Are responsible for oversight of the Moderate Sedation and Anesthesia Care Policy b.Assure that the Anesthesiology Staff are available for consultation regarding moderate sedation and anesthesia care practices c.Provide training of persons involved in physiologic monitoring of sedated patients

Responsibilities Unit Managers: a.Assure that service-specific procedures are developed for all areas within their service in which moderate sedation is carried out b.Provide regular review and appropriate quality improvement activities with respect to moderate sedation monitoring and practices c.Recommends necessary credentials for privileging of moderate sedation providers within the service

Responsibilities Medical Staff Providing Sedation or Anesthesia: a.Are responsible for overall supervision of the administration of sedation or anesthesia in compliance with the policy and procedures for sedation and anesthesia care b.Conduct pre-procedural evaluation of the patient, including the determination that the patient is an appropriate candidate to undergo the planned procedure

Responsibilities Medical Staff Providing Sedation or Anesthesia: c.Conduct and obtain informed consent d.Discharge patients from the post-sedation or post-anesthesia recovery area e.Insure accuracy and completion of documentation pre-, intra-, and post- sedation management.

Responsibilities Director for Medical Quality Improvement Office: a.Is responsible for the overall quality of sedation and anesthesia care provided to patients throughout The Medical City

Staffing A minimum of two personnel must be involved in the care of patients undergoing moderate sedation during the entire procedure: 1.The physician who performs the diagnostic, therapeutic or surgical procedure and 2.The individual whose responsibility is directed only to the patient: to administer medication, to monitor the patient, and to observe the patient’s response to both the sedation and the procedure, under the supervision of the physician.

Patient Selection Criteria ASA guidelines for risk classification are utilized in the selection of patients to receive sedation. (Appendix A) This policy and procedure is not applicable to patients in emergent situations.

ASA Physical Status Classification System PS I a normal healthy patient PS IImild to moderate systemic disease PS IIIsevere systemic disease PS IVsevere systemic disease that is a constant threat to life PS Vmoribund patient who is not expected to survive without the operation PS VIbrain-dead patient

Patient Selection Criteria 1.The physician scheduling the procedure is responsible for assigning the patient an ASA classification. 2.All patients falling into ASA classification I-III are eligible for moderate sedation. 3.Patients that meet the criteria for ASA class IV or V require consultation and/or sedation from a member of the Department of Anesthesiology. 4.Ambulatory patients must have competent adult to escort them home.

Planning For Care 1.Pre-procedure Assessment The physician will determine the appropriateness of performing the procedure(s) requiring moderate sedation based upon: a.The patient’s medical, anesthetic, and medical history b.The patient’s current medical condition c.Available diagnostic data d.Risks, benefits and alternatives of the procedure

Planning For Care 2.Education Prior to the sedation procedure, the practitioner will provide the patient/family with information sufficient to obtain an informed consent which should include risks, benefits, and alternatives to the procedur. Age, emotional, safety and psychosocial needs of the patient will be considered. All outpatients must be accompanied by a responsible adult during this process.

Planning For Care 2.Education b. Include written discharge instructions to patient and accompanying adult which include but are not limited to the following: B1. should not drive or engage in activities requiring balance/coordination for up to 24 hours following the procedure B2. must have some alternate means of transportation home; B3. may experience some dizziness/ balance problems; B4. Should not drink alcoholic beverages;

PRE-PROCEDURE 1.Validate correct patient using two patient identifiers: ask patient or guardian name and date of birth and compare to patient’s medical record. 2.A comprehensive sedation record shall be used for documentation and will also serve as the physician order sheet. 3.The elective patient shall fast for two hours from clear liquids, six hours from milk and solids prior to the procedure.

PRE-PROCEDURE Pre-Induction Assessment At a minimum, assess and document the following prior to sedation: a.Level of consciousness b.Age and weight c.Vital signs d.Baseline physical assessment e.ASA categories 1-5 (see anesthesia/sedation record)

PRE-PROCEDURE A “time out” should be conducted for final verification of correct patient, procedure, site, and as applicable, implants.

INTRA-PROCEDURE 1.The physician shall be present when medications to induce sedation are given. 2.During the procedure, and post-procedure, the healthcare provider monitoring the patient should have no other responsibilities that would result in the patient being left unattended or compromise of monitoring.

INTRA-PROCEDURE 3.Documentation of the following (every 15 minutes or more frequently as dictated by patient condition during the procedure) on the anesthesia/sedation record: a.Heart rate b.Respiratory rate c.Pulse oximeter reading d.Blood pressure e.Responsiveness of the patient/ level of consciousness f.Pain level

INTRA-PROCEDURE 4.The patient is monitored for potential adverse reactions to the medications being administered. Any adverse signs or symptoms are to be reported to the physician immediately and documented. Any actions taken to correct vital signs deviations during the procedure should be documented. 5.In the event of a cardio-respiratory arrest the Code 99 resuscitation protocol will be initiated.

POST-PROCEDURE 1.Patients receiving sedation are monitored by a qualified health care provider until discharged. 2.All vital signs and assessment data will be documented on the anesthesia/ sedation record every 15 minutes and PRN (or as determined by the physician). 3.Discharge from the treatment area will be in accordance with discharge criteria.

POST-PROCEDURE 4. Documentation of sedation should include Vital signs and post-anesthesia recovery score at or near pre-sedation level Pulse oximeter reading at or near pre-sedation level Patient is alert and easily arousable with protective reflexes are intact Nausea, vomiting, dizziness minimal The patient can talk (if age appropriate) The patient can sit unaided or lift head from pillow on command The state of hydration is adequate Pain relief is satisfactory Written discharge instructions provided

CRITERIA FOR TERMINATION OF MONITORING OF PATIENTS Clearance Procedure: Patients will be observed for a minimum of 45 minutes, with vital signs assessments taken at 15-minute intervals post-procedure. –An order for clearance will be written, dated, timed and signed by the responsible practitioner. Monitoring may be terminated when the patient: –Maintains a patent airway with no evidence of respiratory depression –Resumes or maintains baseline Oxygen saturation –Is fully awake and follows commands appropriately –Exhibits protective reflexes –Has baseline/ stable vital signs –Has minimal discomfort –Site of invasive procedure is without complication

CRITERIA FOR DISCHARGE OF OUTPATIENTS Outpatients will also meet the following criteria: –Ability to ambulate consistent with age/ medical condition –Minimal nausea –Minimal discomfort –Ability to tolerate fluids orally –Be alert and oriented –Ability to void voluntarily

CRITERIA FOR DISCHARGE OF OUTPATIENTS Responsible adult will be provided with written and oral discharge instructions and a phone number to be called in case of emergency. Outpatients must be accompanied by a responsible adult. If the patient does not meet the above criteria, a decision will be made by the qualified practitioner to retain the patient in the unit for further observation or, if necessary, to admit the patient to an appropriate inpatient unit.

CRITERIA FOR TRANSFER OF INPATIENTS Inpatients may be transferred following termination of monitoring. The report given to the receiving staff will include: –Procedure performed –Medication(s) administered –Vital signs, cardiac rhythm, oxygen saturation –Patient condition

DOCUMENTATION Practitioners will document in the medical record: –Procedure performed –Medications administered –Complications, if any –Assessment, vital signs, and other health data pertinent to pre-, intra-, and post-procedure –Patient responses to procedure/ medications –Patient/ family instructions given

PROCESS and OUTCOME MEASUREMENT Any manual intervention on the patient’s airway Any loss of consciousness Any prolonged adverse effects of medications Any use of reversal agents Any unanticipated hospital admissions Any cases in which SpO2 is less than 90% for 5 minutes, or less than 80% at any time

SUMMARY These guidelines apply to patients undergoing moderate or procedural sedation anywhere in TMC. Only credentialed and privileged MDs and assists are authorized. Only ASA I-III patients can undergo moderate sedation without anesthesiologists. Inpatient standards for pre-, intra- and post- procedure care of patients undergoing moderate sedation apply. Inpatient documentation and quality assurance standards also apply.