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Procedural Sedation by Non-Anesthesia Providers Learner Outcomes: • • • • • • • • • • • Identify sedation levels according to the Joint Commission’s definitions Describe anticipated patient responses for each level of sedation List the required pre-procedural patient assessments Describe the components of an airway assessment Indentify the required assessments and monitoring parameters during procedural sedation Identify appropriate medications for procedural sedation Identify the role for reversal agents and describe monitoring parameters List the common complications associated with procedural sedation Discuss the management of the common complications Recognize the components of post-procedural assessment and care Identify the required criteria for patient discharge after receiving procedural sedation What is Procedural Sedation? Procedure: A series of steps taken to accomplish an end. Examples: EGD, bronchoscopy, fracture/dislocation reduction, cardiac catheterization Sedation: Reduction of anxiety, stress, irritability, or excitement through the administration of a sedative agent or drug Procedural Sedation: Reducing anxiety or stress with medications in order to perform a procedure. These medications may include, but are not limited to Opiates (e.g., morphine, fentanyl) and Benzodiazepines (e.g., midazolam, lorazepam) Objectives of Procedural Sedation Maintain adequate sedation with minimal risk Provide relief from pain and other noxious stimuli Relieve anxiety and produce at least partial amnesia Preserve modesty Prompt and safe return to activities of daily living For many procedures, procedural sedation has replaced the use of general anesthesia because it : Is easier on the patient Reduces potential complications Definitions: Four Levels of Sedation and Anesthesia (per TJC) 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. Patient is fully responsive Definitions: Four Levels of Sedation and Anesthesia (per TJC) Moderate sedation 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. Stable vital signs, intact airway Responds to verbal stimulation – may utilize light touch to support verbal stimulation Follows simple commands Definitions: Four Levels of Sedation and Anesthesia (per TJC) Deep sedation 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. Responds to repeated or painful stimulation Does not follow commands but may can move spontaneously Respiratory depression is possible: may include decreased respiratory rate and/or difficulty maintaining an open airway BP and pulse remain stable Definitions: Four Levels of Sedation and Anesthesia (per TJC) Anesthesia Consists of general anesthesia and spinal or major regional anesthesia. It does not include local 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 depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function might be impaired. Depression of life sustaining functions (may include respiratory depression and/or change in BP and pulse) No response to stimulation, even painful stimulation Sedation Continuum – Movement from one level of sedation to another is a dose-related continuum that depends on patient response MODERATE SEDATION DEEP SEDATION Responsiveness MINIMAL SEDATION (ANXIOLY SIS) Normal response to verbal stimulation Airway Unaffected Spontaneous Ventilation Unaffected Adequate May be inadequate Cardiovascular Function Unaffected Usually maintained Usually maintained Purposeful response to verbal or tactile stimulation Purposeful response following repeated or painful stimulation No intervention Intervention required may be required ANESTHESIA Unarousable even with painful stimulus Intervention often required Frequently inadequate May be impaired Sedation level is dependent on patient response NOT external factors or type, dose, route of medication. Procedural Sedation is NOT: Chemical Restraint: Medication given for behavioral management or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition Pain Control: Although some of the same medications are given for pain control, the intent of the intervention is different Anxiolysis: A medication given to relax the patient Additional information: Side rails are NOT restraints when used as safety precautions during procedural sedation as long as the DOCUMENTATION is there! Can be up on carts for procedure and recovery period, then removed! Procedural Sedation by Non-Anesthesia Providers Moderate Sedation = Procedural Sedation Policy is applicable throughout the institution (See BJWCH policy) Applicable to all health care providers when anesthesia personnel not present. Proceduralist Physician, Dentist, or Podiatrist Person performing the procedure Hospital Privileges must include Procedural Sedation Assistant A credentialed Registered Nurse The person who monitors the patient during the procedure Some situations require more than one assistant—e.g. one person to assist the Proceduralist and one to solely monitor the patient The person monitoring the patient and/or the person performing the procedure (Proceduralist) must be prepared and competent to treat one level lower than the anticipated sedation level. The most common indication the patient may be beyond moderate sedation into deep sedation is respiratory depression, frequently identified through a drop in pulse oximetry (Sp02 ). If the patient develops significant respiratory depression, the Proceduralist and Assistant must be prepared to support the patient's airway through the use of oral/nasal airways and bag-mask ventilation. In addition, the Proceduralist must be prepared to insert a definitive airway [i.e., endotracheal intubation or laryngeal mask airway (LMA)]. Properly inserted LMA Assistant Responsibilities Patient assessment and interventions Appropriate documentation throughout the procedure Reassure patient and monitor patient awareness and responses. Provide comfort measures as needed Notify Proceduralist of changes/concerns Documentation of required parameters The Assistant is not to leave patient bedside for any reason during the procedure (although may assist the Proceduralist with short interruptible tasks). The assistant must be able to drop those tasks if the patient needs attention) Pre-Procedural Assessment Steps Include: 1. Informed Consent (risk, benefits, alternatives for both procedure & sedation) 2. Physical Assessment: • Based on Health History and Review of Systems • “Focused Assessment” includes basics • Heart & Lung • Whatever else is appropriate 3. Airway Assessment: • • • • • 4. 5. 6. 7. Dentures, loose teeth Inability to open mouth Cervical arthritis/kyphosis Other Structural issues Prepare for the possibility of airway management issues Home/Present Medications Planned Level of Sedation Identified Risk Level (ASA PS Score) Site Marking Mallampati Scoring Responsible Individual for Discharge Patient is accompanied by a responsible adult at discharge The person who will provide the patient’s ride home and be available to the patient after the procedure must be identified before the procedure begins For outpatients, this person frequently accompanies the patient to the hospital If the responsible individual is not present, hospital staff need to verify the individual by telephone If the patient is an inpatient, it might not be necessary to identify this individual pre-procedure. If the inpatient is discharged within 24 hours of the procedure, the patient must be discharged to a responsible individual For outpatients: If either the Proceduralist (person performing the procedure) or the Assistant (person monitoring the patient) believes the individual would not be appropriate for this role or the patient has no one identified, the Proceduralist will determine: ;1r Can the procedure be cancelled/postponed until a responsible individual is available? Should the procedure be completed and the patient kept an additional 4 hours after discharge? Informed Consent • The person performing the procedure (Proceduralist) is to review the objectives, risks, benefits of both the procedure and the plan for sedation • May be completed at the same time the procedure consent is obtained • Informed consent for the sedation does not require a patient signature, but is completed by checking the box on the PreProcedure/Pre-Sedation Assessment Form. If paper forms are not available, it is the responsibility of the Proceduralist to document the patient’s consent for sedation in the pre-procedure note • If the patient has questions, the Proceduralist will be contacted to answer patient questions before consent is signed (witnessed) Assess NPO Status Adult patients undergoing sedation for elective procedures may not eat solid foods or drink nonclear fluids for six hours before administration of sedation. Patients may have clear liquids up to two hours before the procedure Options for the patient not within these guidelines: Cancel or postpone the procedure In urgent, emergent, or other situations when gastric emptying is impaired, the clinician may proceed with the procedure after considering the potential for pulmonary aspiration of gastric contents, the nature of the intervention, and the degree of sedation Risk Assessment: American Society of Anesthesiologist (ASA) PS (Physical Status) Classification ASA PS correlates with overall risk Needs to be used as a tool along with other factors such as type of procedure, medications, and clinician comfort Definition ASA PS 1 ASA PS 2 A normal healthy patient Details Examples Healthy individual with no systemic disease and undergoing elective surgery. Patient not at extremes of A fit patient with inguinal hernia. age. (Note: Age is often ignored as affecting operative risk; however, Fibroid uterus in an otherwise in practice, patients at either healthy woman. extreme of age are thought to represent increased risk). Individual with one system and well-controlled disease. Disease does not affect daily activities. Other anesthetic risk factors, A patient with mild including mild obesity, alcoholism, systemic disease and smoking can be incorporated at this level. Non-limiting or only slightly limiting organic heart disease. Mild diabetes Essential hypertension Anemia Risk Assessment: ASA PS (Physical Status) Classification (continued) Definition Details Examples Severely limiting organic heart disease. ASA PS 3 A patient with severe systemic disease ASA PS 4 A patient with severe systemic disease that is a constant threat to life Severe diabetes with vascular Individual with multiple system complications. disease or well controlled major system disease. Disease status Moderate to severe degrees of limits daily activity. However, pulmonary insufficiency. there is no immediate danger of death from any individual disease. Angina pectoris or healed myocardial infarction. Organic heart disease showing Individual with severe, marked signs of cardiac incapacitating disease. Normally, insufficiency. disease state is poorly controlled or end-stage. Danger of death Persistent anginal syndrome or due to organ failure is always active myocarditis. present. Advanced degrees of pulmonary, hepatic, renal, or endocrine insufficiency. Risk Assessment: ASA PS (Physical Status) Classification (continued) Definition ASA PS 5 ASA PS 6 Details Patient who is in imminent danger of death. Operation deemed to be a last resort attempt at preserving A moribund patient life. Patient not expected to live not expected to through the next 24 hours. In some survive (24 hours) cases, the patient may be relatively healthy prior to catastrophic event, which led to the current medical condition. Examples Burst abdominal aneurysm with profound shock Major cerebral trauma with rapidly increasing intracranial pressure Massive pulmonary embolus A declared braindead patient/organ donor "E" is added to the ASA PS number when the procedure is done on an emergency basis. This indicates that there is an increased risk due to the emergence of the patient's condition, preparation, or required procedure. Prevent: Wrong Site / Wrong Patient/ Wrong Limb / Wrong Equipment Site Verification: Marking is done by marking "YES“ on the procedure site • • • • Responsibility of the Proceduralist Site marking is required for cases involving right/left distinction, surfaces (flexor/extensor); multiple structures (such as fingers, toes) or multiple lesions, wounds, or levels (such as the spine) Completed before the procedure begins Marking should include the patient’s input, verification, and understanding For more information, see the BJWCH policy: Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery Preparation for the Procedure • Obtain IV access • Have emergency/resuscitative equipment immediately available: • • • • • Method of Positive Pressure Ventilation--Ambu Bag Laryngoscope/ET Tubes Emergency Drugs (especially reversal agents) Oxygen delivery devices & Functioning Suction Crash Cart / Respiratory Box • Patient Monitors: • Noninvasive blood pressure machine • Cardiac Monitor • Pulse Oximetry / Capnography (optional) • Perform the Time Out Prevent Wrong Site / Wrong Patient Wrong Limb / Wrong Equipment COMPLETE THE “TIME OUT”! The “Time Out” is completed immediately before the first dose of sedation/start of the procedure All members of the procedural team will verbally acknowledge their agreement to the following elements as applicable to the procedure: Patient identity Procedure to be done Confirmation that correct site/side is marked and visible Correct patient position Consent form accurately and correctly completed Relevant image/test results correctly labeled and displayed The need to administer antibiotics or fluids for irrigation purposes Any safety precautions based on patient history or medication use Intra-Procedural Monitoring Requirements REQUIRED - documentation at least every 10 minutes, or more frequently if indicated: BP Pulse Respiratory Rate SpO2 (Continuous Pulse Oximetry) Sedation Level (RASS) End Tidal CO2 Capnography (optional) REQUIRED—Cardiac Monitoring Assistants (Procedural Sedation Credentialed RNs) will be able to utilize rhythm interpretation as a tool to identify when more in-depth patient assessment is required: Example #1: Heart rate drops – assistant may stimulate patient, check BP, etc. Example #2: Heart rate accelerates – assistant may ask patient about comfort level Assistants should notify the clinician for any noticeable changes in rhythm, rate, or other concerns noted on monitor for further medical direction. Intra-Procedure Monitoring Requirements Level of Sedation: Assessed with vital signs and documented Richmond Agitation Sedation Scale (RASS) used for sedation assessment Richmond Agitation Sedation Scale (RASS) Score Term (this column is not included on forms) Description +4 Combative Overtly combative, violent, immediate danger to staff +3 Very agitated Pulls or removes tubes(s) or catheter(s), aggressive +2 Agitated Frequent, non-purposeful movement. Fights ventilator +1 Restless Anxious but movements not aggressive, vigorous O Alert and Calm Alert and Calm -1 Drowsy Not fully alert but has sustained awakening (eye opening/eye contact to voice, > 10 seconds) -2 Light sedation Briefly awakens with eye contact to voice, <10 seconds -3 Moderate sedation Movement or eye opening to voice (but no eye contact) -4 Deep sedation No response to voice but movement or eye opening to physical stimulation -5 Unarousable No response to voice or physical stimulation Types of Complications: Complication Causes: Generally due to over dosage of sedative and analgesic drugs. May also may be due to drug-drug interaction. Consider patient age, medical history and size Types of Complications: Respiratory depression: resulting in hypoxemia and /or hypercarbia • May show as a drop in O2 Saturation or Respiratory Rate • May be related to a changing level of sedation, i.e. going from Moderate Sedation to Deep Sedation Cardiovascular depression: Hyper- or hypotension, brady- or tachycardia • Observe trends in blood pressure and pulse • Proceduralist is to be notified if cardiac rhythm changes Aspiration: • Silent regurgitation is more likely to happen when the patient is over sedated • Only evidence may be changes in oxygen saturation, changes in breath sounds, or skin color Treatment for Potential Complications Respiratory depression • Stimulate the patient (may be all that’s needed) • • • • • • • Chin Lift Oral/Nasal Airway Oxygen-increase flow if already on O2 Positive Pressure Ventilation (bag-valve mask) Consider use of emergency equipment (LMA, ET tube) Consider use of reversal agent Call Anesthesia Aspiration • • • • Suction Consider intubation Chest X-ray Bronchoscopy if particulate matter For any complication, consider ACLS Guidelines or calling a RRT/Code (x8444) Treatment for Potential Complications Hemodynamic instability • • • • • • • Consider fluid bolus/increase IV fluids If patient is bradycardic, consider giving Atropine (0.5mg IV Push) Vasopressors (e.g. dopamine) Antihypertensives (e.g. nitroprusside) Monitor respiratory status and oxygenation Consider use of reversal agent ACLS Protocols For any complication, consider ACLS Guidelines or calling a RRT/Code (x8444) Procedural Sedation Pharmacologic Considerations 3f) Medication Classes Used for Sedation Opiates: Pain control Give medications only allowed by the IV Medication Administration Policy Benzodiazepines : Sedation Watch times of onset. Midazolam IV Push has onset of 3-5 minutes. Lorazepam IV Push takes 10-20 minutes Both opiates and benzodiazepines are frequently administer together Synergist action on the level of consciousness and respiratory depression If the patient is in pain, it is helpful to give analgesics first. As the pain decreases, the patient may more easily respond to sedatives Pain may not be present before the procedure but most procedures are uncomfortable Have reversal agents readily available: Remember, reversing benzodiazipines does not necessarily reverse respiratory depression When reversal agents are given, the patient must be monitored a minimum of 1 hour after the reversal due to possibility of re-sedation Choosing Appropriate Medications Agents should be chosen based on the desired pharmacological response. Depending on the particular agent, one, two, or all three of the effects below can be achieved: Anxiolysis Analgesia Amnesia Adverse effects - The potential side effects of any medication in a particular patient must be considered. Many sedative agents can produce cardiac or respiratory depression Pharmacokinetic Considerations - When selecting a sedative, the following Pharmacokinetic parameters should be considered to optimize response in a given situation Onset and Duration Elimination Route Accumulation Drug Interactions/Potentiations Cross-Tolerance (e,g. patients with prior opiate use may require higher doses of opiates. Those with prior ethanol exposure may require larger doses of benzodiazepines, etc) Pharmacokinetics-Route of Elimination Hepatic Diazepam Midazolam Lorazepam Fentanyl Meperidine Morphine Propofol Renal Diazepam metabolites Midazolam metabolites Morphine metabolites Meperidine metabolites Critical thinking question: How would dosages change if the patient has liver or kidney insufficiency? Drug Interactions CYP3A4 Inhibitors Azole antifungals Diltiazem Verapamil Protease inhibitors Macrolides Nefazodone Quinupristin-dalfopristin Drug Affected Midazolam Opioid Cross-Allergenicity Morphine-like Meperidine-like Morphine Meperidine Hydromorphone Fentanyl Opioids – Equipotent Doses Drug Dose (mg) Fentanyl 0.1 Hydromorphone (Dilaudid®) 1.5 Morphine 10 Meperidine (Demerol®) 75 Benzodiazepines: Cautions: Consider Dose Adjustments: Lower doses require in elderly, debilitated or chronically ill patients Patient who receive concomitant opiates should have the dose reduced by 30-50% Benzodiazepines are cross-tolerant with alcohol, higher doses may be required to achieve sedation in current heavy drinkers. Examples of Benzodiazepine Medications: Midazolam (Versed®) Valium (Valium®) Lorazepam (Ativan®) Midazolam (Versed®) Onset: 1-4 minutes Usual Duration: 30-60 minutes Elimination Route: Hepatic Dose: 1-2 mg IV bolus initially. Additional doses of 1-2 mg may be given at 2 minue intervals to desired effect. Usual maximum does: 0.075 mg/kg (about 5 mg for a 70kg patient) Dose Adjustment: Lower doses are required in elderly, debilitated or chronically ill patients. Patients who receive concomitant opiates should have the dose reduced by 30-50% Potential Adverse Effects: Respiratory depression, apnea, respiratory arrest, hypotension, tachycardia, inability to maintain airway Diazepam (Valium®) Onset: 1-2 minutes Usual Duration: 2-4 hours Elimination Route: Hepatic Dose: 2 mg slow IV push, repeat at 2 minute intervals to desired level of sedation Concerns: Irritating to veins, Significant accumulation can occur, hypotension and bradycardia may occur with rapid injection Potential Adverse Effects: Respiratory depression, apnea, respiratory arrest, hypotension, tachycardia, inability to maintain airway Lorazepam (Ativan®) Onset to maximal effect: 20-40 minutes Usual Duration: 4-6 hours Elimination Route: Hepatic Dose: 2-4 mg slow IV push. Wait at least 30 minutes to assess effect before re-dosing. Concerns: Slow onset, duration can become elimination dependent, accumulation may occur Notes: Less cardiovascular effect than diazepam, less irritating to veins, ½ life less variable, even in hepatic dysfunction, no active metabolites Potential Adverse Effects: Respiratory depression, apnea, respiratory arrest, hypotension, tachycardia, inability to maintain airway Opiate Analgesics Examples of Opiate Analgesics Include: Fentanyl (Sublimaze®) Morphine Meperidine (Demerol®) Fentanyl (Sublimaze®) Onset: 1- 2 minutes Usual Duration: 30-45 minutes Elimination Route: Hepatic (inactive metabolites) Dose: 25-50 mcg (1-2 mcg/kg) IV bolus initially. Additional doses may be given at 5-10 minute intervals Notes: Rapid onset sedative and analgesic effect, synergy with benzodiazepines, minimal histamine release (less hypotension than morphine) Concerns: Tolerance develops, Accumulates over time Potential Adverse Effects: Respiratory depression, apnea, respiratory arrest, hypotension, tachycardia, inability to maintain airway Morphine Onset: 5-10 minutes with a peak at 20 minutes Usual Duration: 2-4 hours (prolonged in elderly with hepatic dysfunction) Elimination Route: Hepatic Dose: 2-5 mg IV bolus, additional doses may be given at 15-20 minute intervals Concerns: Hypotension due to histamine release, may accumulate, tolerance develops, decreases GI motility Potential Adverse Effects: Respiratory depression, apnea, respiratory arrest, hypotension, tachycardia, nausea/vomiting, inability to maintain airway Other Agents: Examples of Other Agents Use for Sedation Include: • Ketamine (Ketalar®) • Propofol (Diprivan®) Ketamine (Ketalar®): Onset: 30 seconds – 1 minute Duration: 15-30 minutes Dosage: 0.2-0.75 mg/Kg over 2-3 minutes Elimination: Hepatic and excreted in the urine and feces Notes: Should be administered with a benzodiazepine to decrease emergence reactions including vivid dreams, hallucinations, and/or delirium. Assistant should have not other duties—only monitoring the patient. Patients should be monitored a minimum of one hour after completion of the procedure Potential Adverse Effects: Tachycardia, systemic and pulmonary hypertension, Hallucinations, vivid dreams, delirium Propofol (Diprivan®) Onset: 30-60 seconds Duration: Short (pt attain baseline within 10-15 minutes Dosage: 0.3 mg/Kg IV bolus, then 1-3mg/kg/hour infusion Elimination: Hepatic Notes: Rapid onset sedative with NO analgesic effect. Tolerance develops, Urine turns green Potential Adverse Effects: Respiratory dpression, Apnes, Respiratory Arrest, Hypotension, Inability to maintain airway BJWCH RN’s may not administer an IV boluses of Propofol for Procedural Sedation. If this agent is used, the Proceduralist will need to administer the bolus. Reversal Agents Naloxone (Narcan®) Flumazenil (Romazicon®) Reverses Opiates Benzodiazepine Dosing 0.4-2 mg q 2-3 min, up to 10 mg 0.2 mg q 1 min, up to 1 mg Onset 1-2 min 1-2 min Duration 30-60 min 30-90 min Adverse Effects Can precipitate withdrawal, pulmonary edema Seizures Reversing BZD-induced hypoventilation has not been established Post-Procedural Requirements Procedural Orders: • Orders given orally throughout the procedure must be written in the patient medical record or entered via computerize provider order entry (CPOE) • If the assistant is utilizing handwritten documentation forms, the Proceduralist’s signature, date, and time must be included on the bottom of the monitoring form. • A post-procedural note must be documented in the patients medical record Monitoring Requirements: • Blood Pressure, Pulse, Respiratory Rate, and SpO2 are to be documented every 10 minutes (more frequently, if indicated) • An Aldrete Score must be completed upon completion of the procedural and with each vital sign documentation during the recovery period ALDRETE POST PROCEDURE RECOVERY SCORE A Baseline Pre-Procedural Aldrete Score must be obtained before sedation is initiated, because the PostProcedural Aldrete Scores are compared to the baseline score A Post- Procedural Aldrete Score is obtained at the end of the procedure and then repeated every 10 minutes until the patient meets discharge criteria. To meet discharge criteria, a minimum of two (2) consecutive Aldrete Scores AFTER the end of the procedure must be at the baseline score or the baseline score minus one with stable vital signs Discharge Criteria Discharge Criteria (cont.) • In the event that reversal agents (naloxone, flumazenil) were used, allow a minimum timeframe of 1 hour after the last dose to ensure that the patient does not become resedated after reversal effects have abated • Patients who will be discharged to home and received IV medications for relief of pain, nausea, and/or vomiting, etc. must be observed for no less than two (2) Aldrete/vital sign assessments following the administration of such medication • Critical thinking: If the patient has liver/kidney insufficiency, metabolism and/or excretion of the drugs might be impaired. This might prolong the effect of the drug(s) resulting in a need for longer recovery-area time Discharge Instructions Discharge Instructions Need to Include: Purpose and expected effects of sedation Patient's post-discharge care Emergency phone number Post-discharge Medications Dietary/activity restrictions No driving for 24 hours Avoid alcohol for 24 hours Other instructions appropriate for the procedure References • ASA (2002). Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. Anesthesiology 2002; 96:1004-1017. • The Joint Commission (2011) Comprehensive Accreditation Manual for Hospitals. • Department of Health and Senior Services (DHSS) Centers for Medicare and Medicaid Services (CMS) Conditions of Participation: Anesthesia Services. 1