Care of Patients Undergoing Moderate and Deep Procedural Sedation

Purpose: To provide clinicians with guidelines for procedural sedation use that will promote the benefits of sedation while minimizing the associated risks. Policy: All moderate and deep procedural sedation performed at HCMC shall be done in accordance with the American Society of Anesthesiology guidelines and the Joint Commission on the Accreditation of Health Care Organizations standards. Sedation used within the scope of this policy addresses the need to decrease anxiety, assist in the management of pain, moderate physiologic responses to stress during a diagnostic procedure or patient treatment, and expedite procedures in uncooperative adults and children that require the patient remain still. This policy applies to all patient care areas where moderate and/or deep procedural sedation is used. Since sedation is a continuum, this policy is designed to provide for a safe level of patient care at any level of sedation, including those patients who achieve a deeper level of sedation then originally intended and who may lose their ability to maintain independent ventilatory function. This policy is not intended to cover sedation which results from the use of drugs that are primarily intended to alleviate severe pain over time, provide minimal sedation (anxiolysis), sedate for ventilator management, provide analgesia via intrathecal or epidural routes, address post-operative pain, manage continuous seizures or alcohol withdrawal, treat psychiatric illness, or manage behavior in cognitively impaired patients.

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With the new procedural sedation there are 4 levels of sedation.

LEVEL 1 MINIMAL SEDATION:

A drug-induced state during which patients respond swiftly to verbal commands. The patient’s airway, spontaneous ventilation and cardiovascular function are unaffected. Minimal sedation corresponds to a Ramsey Sedation score of 1, 2 or 3.

LEVEL 2 MODERATE SEDATION

formerly known as “conscious sedation” A drug-induced depression of consciousness during which patients have a delayed or sluggish response (appropriate for their developmental age) 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.

LEVEL 3 DEEP SEDATION

A drug-induced depression of consciousness during which patients cannot be easily aroused, but respond appropriately for their developmental age following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired.

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LEVEL 4 ANESTHESIA

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.

ASA Classification One tool used to determine a patient’s risk for anesthesia is the ASA Classification tool listed below. ASA Class

Definition

I

A normal, healthy patient

II

A patient with mild systemic disease and no functional limitations (e.g., tobacco use, controlled hypertension, controlled diabetes)

III

A patient with moderate to severe systemic disease that results in some functional limitations (e.g., COPD, asthma, CHF, CRF, uncontrolled diabetes).

IV A patient with severe systemic disease that is a constant threat to live and is functionally incapacitating (metastatic CA, cardiomyopathy)

ASA Class V is assigned only in those patients who are not likely to survive with or without the planned procedure/surgery.

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Personnel

Providers: Physicians or Licensed Independent Practitioners (LIPs) who oversee care of patients. Sufficient numbers of qualified personnel are present during a procedure. Minimum requirement is one person to complete procedure, and one person to monitor patient

Monitoring personnel: Provide the medication used to produce sedation. Continuously monitor the patient. May assist with minor, interruptible tasks, but shall not leave patients side.

Educational Requirements: BLS. Completion of the sedation self-learning packet (new version available 2003). Demonstration of competency in the following:

o Proper oxygen administration. o Use of bag/valve/mask apparatus for ventilation. o Use of suction equipment on the “crash” cart. o Use of pulse oximetry. o Ability to obtain IV access.

For moderate sedation with high risk patients (ASA score of IV or V) or deep sedation, all of the above plus:

o ECG monitoring. o Advance life support for appropriate for patient age.

Planning begins when the procedure is first scheduled.

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High Risk Patients High-risk patients are considered any patients receiving deep sedation and those whose pre-assessment reveals any of the following:

*Documented history of difficult intubation and /or adverse sedation/anesthesia reaction ** Presence of a difficult airway ** ASA score of IV or V ** Uncontrolled COPD, Asthma, CHF, HTN ** Current arrhythmia

*Must notify Anesthesia prior to moderate-deep sedation **May need to notify Anesthesia prior to sedation

Age Specific Considerations: Why are age specific considerations important?

To provide for Individual Patient Assessment To provide for patient safety

What are the high-risk age groups for procedural sedation?

Infants/toddlers Older adults

What is a key item for the following developmental stages?

Pediatric – Fear, difficulty with comprehending necessity of procedure Adult – loss of independence or control Geriatric – Fear, may have cognitive or physiologic deficits

Pediatrics:

Physiologic Differences: Dosing per kilogram only – size is important Airway – small size – large head – large tongue Circulatory – difficulty with peripheral access

What is important? Establish trust with patient and family – especially if culturally different Fully informed consent (parents, guardian, emancipated minor)

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Sensory information given pre, intra, and post procedure, including education Monitoring O2 saturation

Gerontologic:

Physiologic Differences Other physiologic challenges (e.g., hypertension, heart disease, renal insufficiency) Alteration in drug metabolism and excretion Altered sensorium – loss of senses, dementia

What is important? Obtaining thorough medical history and physical history Altering dosages as necessary Sensory information given pre, intra and post procedure, including education

Outpatients Must arrange a designated driver. Must have a responsible adult who can be immediately available to the patient at home post-procedure. The procedure shall be rescheduled if ride and caregiver arrangements have not been made. Pre-sedation/procedure education should be given to the patient at least a day prior to the planned procedure. Often information can be printed from the HCMC Intranet.

All Patients must be monitored for: Respiratory rate Heart rate Blood pressure Oxygen saturation

Equipment required for sedation: Equipment must be size appropriate. Basic monitoring equipment includes:

♦ pulse oximeter

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♦ blood pressure monitor ♦ stethoscope

The following should be readily available: ♦ EKG with defibrillator, ♦ suction, ♦ oxygen delivery devices (masks, cannulas, positive pressure bags,

oral and nasopharyngeal airways, laryngoscopes, and endotracheal tubes).

Monitoring begins before sedation.

A sedation plan is required prior to beginning sedation. The intended level of sedation must be indicated. A baseline oxygen saturation, blood pressure and respiratory rate must be obtained. There is an existing H&P that has been completed within thirty days prior to the procedure. If the H&P was not written within the past 7 days, an addendum must be added stating current health status. Complete pre-assessment within 24 hours of procedure, and include it in the medical record.

Minimal Procedural Sedation

What is it? Minimal sedation is a drug-induced state during which patients respond swiftly to verbal commands. The patient’s airway, spontaneous ventilation and cardiovascular function are unaffected. Minimal sedation corresponds to a Ramsey Sedation score of 1, 2 or 3: 1= Patient anxious, agitated or restless. 2= Eyes open (unless asleep), cooperative, oriented, tranquil. 3= Eyes closed, responds to verbal commands. When is it used? Minimal procedural sedation is used to assist patients with the control of mild anxiety and pain when undergoing procedures that are not likely to cause more severe anxiety or pain.

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Prior to Giving Minimal Sedation: What do I need to do for my patient?

Have a B/P cuff or NIBP, pulse oximeter, O2 and suction on hand. Verify the presence of consent (if needed for the procedure). Review current medications, allergies and/or past anesthesia reactions. Assess and document (or review) the following baseline data: Heart and lung sounds. vital signs, SpO2, LOC and Ramsey Sedation Scale score. Tell the patient what to expect during the sedation and procedure.

For outpatients: Prior to the day of the procedure (when possible) instruct the patient that they cannot drive themselves home. Minimal Sedation Medication Administration and Patient Response: What do I need to do for my patient? Monitor and Document:

Medications Given: o For IV Sedation: Reassess patient’s SpO2 and Ramsey sedation

level 5 minutes after each dose of IV medication (or more frequently as patient condition warrants).

o For PO Sedation: Reassess patient’s SpO2 and Ramsey sedation level 30 minutes after each dose of medication (or more frequently as patient condition warrants).

Interventions required, such as O2 delivery. Changes in condition and/or adverse effects and report to the physician. *If the medication is given in a location other than where the procedure will take place, the patient must be reassessed prior to transfer OR be transported to the procedural area by staff qualified to monitor and reassess the patient.

Required Monitoring after the Completion of Procedures with Minimal Sedation: What do I need to do for my patient?

Assess and document SpO2, Ramsey sedation level and LOC (orientation to person, place and time).

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Continue to monitor the patient until SpO2, sedation level and LOC return to pre-procedure baseline. Notify the responsible physician if the patient does not meet the criteria specified within the anticipated recovery time. Give the patient and/or caregiver post-procedure instructions as appropriate.

* If at any point the patient progresses to a moderate or deep level of

sedation, follow the intra and post-procedure patient care guidelines as outlined in the Care of Patients Undergoing Moderate and Deep Procedural Sedation policy.

* Patients cannot drive themselves home following minimal sedation. Minimal Sedation Documentation: Where do I document patient assessment and monitoring before, during and after minimal procedural sedation?

For inpatients, use the appropriate areas on the patient care flow sheet. For outpatients, use the appropriate areas on the procedural forms used by your department.

Moderate and Deep Procedural Sedation Intra-procedure Responsibilities: Monitoring personnel shall:

Perform and document an immediate reassessment of the patient just prior to the administration of sedation (vital signs and SaO2) to ensure that the patient remains a candidate for procedural sedation. Monitor and document the patient’s vital signs every 5 minutes, or more frequently as necessary. Monitoring methods depend on the patient’s pre-procedure status, sedation or anesthesia choice, and the complexity of the procedure. Assess the patient continuously for changes in condition and adverse effects, and report to the physician/LIP.

Monitoring personnel may assist with minor, interruptible tasks during procedures, but shall not leave the patient’s side.

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Post-procedure Responsibilities: Sedation Recovery for Inpatients Qualified Monitoring Staff shall:

Monitor and document the patient’s vital signs every 5 – 15 minutes until the patient’s Phase I Recovery Criteria score is 9 or 10 (See following page), or returns to pre-procedure baseline. Patients must score 2 in both Circulation and Respiration to pass Phase I Recovery Criteria. Notify the physician/LIP if the patient does not meet the criteria specified above after the anticipated recovery time has passed. Once the patient meets Phase I Recovery Criteria, monitor and document the patient’s vital signs as per post-procedure/post-operative orders. Assess pain level as needed throughout recovery and follow HCMC pain standard of care. Upon completion of all post-sedation monitoring, complete the necessary documentation including a statement regarding the patient’s condition and destination if appropriate. Document patient outcomes/events.

Sedation Recovery for Outpatients Qualified Monitoring Personnel shall:

Monitor and document patient’s vital signs every 5-15 minutes until the patient’s Phase I Recovery score is 9 or 10, or Respiration returns to baseline. Patients must score 2 in both Circulation and to pass Phase I Recovery Criteria Notify the physician/LIP if the patient does not meet the

criteria specified above after one hour post-procedure. Once the patient meets Phase I Recovery Criteria,

monitor and document the patient’s vital signs every 30 minutes or more frequently as patient condition warrants, or as post-procedure orders indicate, until the

patient meets Phase II Recovery Criteria (See following pages), or returns to pre-procedure baseline. Report to the physician, met as appropriate, any Phase II Recovery Criteria not.

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Assess pain level as needed throughout recovery and follow HCMC pain standard of care. Provide discharge instructions to patient and/or caregiver. Patients are ready to be discharged to home, when the Discharge to Home Criteria is met. Upon completion of all post-sedation monitoring, complete the necessary documentation including a statement regarding the patient’s condition and destination if appropriate. Document patient outcomes/events.

Phase I Recovery Criteria (Acute) Assessment Category

Requirements to pass Phase I Recovery

Criteria

Activity Must be at baseline to go to floor or Phase II

Able to move 2 extremities and sustain head Able to move two extremities and cannot sustain head Unable to move extremities or sustain head

2 1 0

Respiration Must score 2 to go to floor or Phase II

Age appropriate respiratory rate/coughs and clears airway Dyspnea or limited breathing / airway requires maintenance Apneic/intubated/mechanically ventilated

2 1 0

Circulation Must score 2 or to go to floor or Phase II

BP/HR WNL (B/P and HR + 20% of baseline) BP/HR outside of normal limits requiring close observation BP/HR requires intervention

2 1 0

Consciousness Must be at baseline to go to floor or Phase II

Fully Awake (Ramsey 1, 2 or 3) Arousable (Ramsey 4) Not responding (Ramsey 5 or 6)

2 1 0

O2 Saturation Must score at least 1 to go to floor or Phase II

Room air saturation of >94% or at baseline Requires O2 to maintain saturation >90% O2 saturation <90% with supplemental O2

2 1 0

Total

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Phase II Recovery Criteria (Discharge Criteria)

CRITERIA YES NO NA Alert, oriented or as pre-op Ambulatory or as pre-op Absence of respiratory distress (SaO2 >94% or at baseline) Vital signs stable (BP and HR + 20 % of baseline) Able to take fluids PO Voided Nausea / vomiting / dizziness minimal Good circulation in operative extremity Bleeding, drainage minimal Pain / discomfort acceptable to patient Discharge meds or Rx given and explained Discharge instructions given and explained Verbalized understanding of instructions IV discontinued Discharge to adult Follow-up appointment arranged Property/valuables returned

Patients shall not be discharged to home until all applicable criteria have been met or until physician has evaluated patient

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Moderate/Deep Sedation Documentation

Pre-procedure::

MD/LIP: ((Use“Moderate and Deep Procedural Sedation Note”) (see example 1) Complete the following:

Physician Pre-procedure Moderate/Deep Sedation Assessment Sedation Plan

Monitoring Staff:: (Use appropriate format for your area: On-line charting, revised Patient Care Flowsheet, or the new “Procedural Sedation Monitoring Record” form.)

Complete the following: NPO status, height and weight Verify informed consent Patient/family instructions Sedation goal (4 or 5 on the Ramsey Sedation Scale) Document Baseline Data: BP, HR, RR, O2 Saturation level, pain score, LOC, and Phase 1 Recovery Score If ECG monitoring needed record the Cardiac Rhythm Immediately prior to sedation, document a reassessment of vital signs and O2 saturation level to ensure the patient is still a candidate for sedation.

Intra-procedure:

Monitoring Staff: Complete the following:

Start & end times of the procedure Vital signs (BP, HR, RR, and O2 saturation level) every 5 minutes or more frequently as necessary. Changes in the patient’s condition and adverse effects and report to the MD/LIP.

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Post-procedure (All patients): MD/LIP: Complete the following: (see example 1)

Date, Time & Signatures Post-procedure note:

o Findings o Procedural complications o Blood loss o Specimens removed o Post-procedure/sedation plan of care

Post-sedation note: o Level of sedation achieved o Sedation complications

Monitoring Staff: Complete the following: Phase 1 Recovery:

Vital signs every 5-15 minutes until the patient’s Phase 1 recovery score is 9 or 10 or returned to baseline. Assessment and management of pain Notification of MD if the patient does not meet Phase 1 Recovery Criteria in the anticipated timeframe. Patient condition and destination if applicable. Patient outcomes/events (on Moderate/Deep Procedural Sedation Note

Post-procedure (Outpatients):

MD/LIP: Complete the following:

Date, Time and Signature Post-procedure note (see example 2):

o Findings o Procedural complications o Blood loss o Specimens removed o Post-procedure/sedation plan of care

Post-sedation note: o Level of sedation achieved o Sedation complications

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Monitoring Staff: After meeting Phase 1 Recovery progress to Phase 2 Recovery Criteria Complete the following: Phase 2 Recovery: Outpatients only

Vital signs at least every 30 minutes until Phase 2 criteria are met. Continued assessment & pain management. Notification of MD if the patient does not meet Phase 1 Recovery Criteria in the anticipated timeframe. Criteria met that indicates readiness for discharge. Discharge instructions

Patient Transportation:

Qualified monitoring staff with the

appropriate equipment shall accompany any patient who is under moderate or deep sedation, or who requires monitoring during transport.

Health Care Assistants and Nursing

Assistants may transport patients who pass Phase I Recovery Criteria.

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