Healthcare professionals can benefit from a model designed to increase awareness and develop, implement, and monitor outcomes of a procedural conscious sedation program.
By Gary J. Hospodar, MAOM, RRT, RCP
Much has been written over the past several years documenting the increase in patient care procedures that occur outside the operating room. This is due in part to the introduction of shorter-acting sedatives for sedation and opioids for pain control along with substantial improvements in noninvasive monitoring equipment. As a result, diagnostic and surgical procedures are now being performed in a variety of locations and settings throughout the hospital.
Subsequently, professional organizations have developed and published sedation guidelines. The most notable are the American Society of Anesthesiologists (ASA),1 the American Academy of Pediatrics (AAP),2 and the American Academy of Pediatric Dentistry (AAPD).3 In addition, I will specifically refer to use of the ASA guidelines as the administration of sedation to include or exclude analgesic effects as being akin to the use of anesthesia standards from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).4 Guidelines of other regulatory agencies may apply depending on state department of health and/or human services standards. These agencies should be evaluated on a state-by-state basis for additional regulatory applications in addition to JCAHO guidelines or regulations that may be held in concert with the JCAHO.
When developing a conscious sedation program for any organization, one must begin with the formation of a multidisciplinary team. This team should consist of appropriate representatives of the medical, nursing, administration, and ancillary staff who will be directly involved in practitioner training, competency documentation and verification, patient assessment, administration of conscious sedation medications, their monitoring, and discharge planning functions. From this multidisciplinary committee format, an organizational standard practice procedure must be developed, and a conscious sedation policy designed, approved, and supported by the hospital’s medical executive committee (or similar governing body), and practiced consistently in all areas of the organization where conscious sedation procedures are occurring. Policy practice compliance should also be monitored for outcomes, as well as any other outcome indicators that are appropriate to the organization, procedure, or providing department(s).
Conscious sedation is the use of sedation, and analgesia describes a state of reduced consciousness that allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and to respond purposefully to verbal command and/or tactile stimulation. The hospital is a frightening and anxiety-provoking environment. So, for the patient experiencing a potentially painful or uncomfortable procedure, there are two principal goals in relationship to administering conscious sedative medications. They are to increase patient comfort and decrease pain and anxiety.
To address conscious sedation, one must first delineate two closely related levels of sedation as described by the ASA.5
- assistance with administration of sedative or analgesic medications and the noted patient response is reflex withdrawal to painful stimuli;
- state that requires special care to ensure adequate pulmonary ventilation and hemodynamic stability.
- ability to independently maintain a patent airway; • retain cardiorespiratory reflexes;
- appropriately respond to physical and/or tactile stimuli.
Training and Competency Verification
Once the multidisciplinary team has been developed, been submitted, and received approval from the organization’s medical executive committee, it is incumbent of that committee to assure that practitioners are provided with appropriate training and appropriate age-specific competency verification. The training program should include information that will verify the practitioner as being knowledgeable about techniques, medications, side effects, monitoring devices, response or adverse reactions of medications, and documentation of each procedure they will be responsible for. In addition, all practitioners must meet the organization’s qualifications to be certified as competent in accordance with the organization’s and respective department’s policy by demonstrating the ability to administer sedatives and analgesics under appropriate medical supervision and direct orders of the physician performing the procedures. Other items for procedural responsibility may be closely related to state licensure limitation, professional credentials, and appropriate life support training established by the conscious sedation policy for the organization. It is recommended that competency verification be placed in the practitioner’s personnel file, as well as in a location that is easily accessed for review purposes.
One must always remember that it is not the medication itself that denotes sedation in the patient, but the patient’s individualized response to the administered medication.
It should also be recognized that various degrees of sedation occur on a continuum. A patient may progress from one degree of sedation to another depending on underlying medical status, medication(s) administered, dosage, and route of administration. It is important, therefore, that the monitoring and staffing requirements be based on the patient’s acuity and the potential response of the patient to the procedure. Progress from one level of sedation to another requires appropriate changes in monitoring and observation of the patient. The following must be documented when performing competency verification and when performing the associated procedures.
- knowledge of the goals and objectives of IV conscious sedation;
- patient assessment;
- administration of medications per physician’s orders;
- uninterrupted observation and monitoring of the patient from time of conscious sedation until time of discharge;
- documentation (as described below);
- provision of appropriate emergency intervention as necessary.
- completing history and physical examination;
- completing informed consent;
- ordering the medication, dosage, and route of administration;
- directing and providing emergency interventions as necessary;
- dictating operative note immediately after completion of procedure (as per hospital policy).
- dosages, route, time, and effect of all drugs used;
- type and amount of fluids administered including blood and blood products, monitoring devices, or equipment used;
- heart rate, rhythm, blood pressure, respiratory rate, oxygen saturation, and level of consciousness;
- interventions and the patient’s response to the interventions;
- untoward or significant patient reactions and their resolution or outcome.
Additional guidelines for practitioner training can be found in the ASA’s Practice Guidelines for sedation and analgesia by non-anesthesiologists.6
It is the responsibility of care providers who actively participate in conscious sedation procedures to assess, prepare, and monitor the patient before, during, and after the procedure. A detailed pre-procedure assessment should occur for each patient. Informed consent must be obtained prior to the procedure and prior to the patient receiving sedating medication. Discharge and follow-up instructions may need to be given to the patient prior to sedation, as well as to the person responsible for transporting the patient post-sedation.
|ASA Classification of Patient
|No known systemic disease
|May have conscious sedation without other consultation
|Mild or well-controlled systemic disease
|Multiple or moderate controlled systemic disease(s)
|Consider medical consultation
|Poorly controlled systemic diseases(s)
|Mandatory involvement of anesthesiology department
|Table 1. American Society of Anesthesiology patient classification status.
Conscious sedation is not for every patient—there is an evaluation process that must be considered. The ASA12 (Table 1) recommends that conscious sedation be used for ASA Class I & II patients, as these patients are the lowest risk. Patients classified as ASA Class III may require anesthesia consultation and collaboration by the healthcare team to determine if they are appropriate candidates for conscious sedation, or if anesthesia assistance is needed. ASA Class IV & V patients must have involvement from the Department of Anesthesiology. These patients are not candidates for conscious sedation and must have monitored anesthesia care.
Prior to any conscious sedation medications being administered, all patients must have the following information documented
- medical history;
- evaluation of all major medical organ systems;
- use of alcohol/tobacco/illicit substances;
- previous experience with conscious sedation procedures/anesthesia/analgesics;
- current medications;
- known allergies to any medication;
- baseline vital signs including height and weight; and
- mental status.
It should also be determined when the patient last ate and drank. The recommendation is no solid food or full liquids for at least 6-8 hours and no clear liquids for at least 3-4 hours prior to sedation. In pediatric patients, the time factors are 3-4 hours for food or full liquids and 2-3 hours for clear liquids. In cases where sedation is part of an emergency procedure, careful clinical judgement is required to determine an appropriate level of sedation that does not place the patient at an unacceptable risk for regurgitation and aspiration. The procedure and sedation may be delayed until the risk is diminished. In cases where the procedure can not be delayed without causing further harm to the patient, practitioners should follow guidelines to prevent aspiration as outlined in the hospital’s policy regarding conscious sedation.
Conscious Sedation Medications
Conscious sedation is achieved by administering pharmacological agents. The most common route of administration is intravenous (IV), although medications may be given orally, rectally, intramuscular, intranasally, and through anesthetic gas. The most commonly used agents are opioids, sedatives, dissociative agents, inhalational agents, and reversal agents.
The agents used depend on the type, duration, and intensity of the procedure. Differences in patients’ health status with variable ability to metabolize medications should be considered when selecting and administering the medications. The medications frequently given for conscious sedation are listed in the hospital’s policy on conscious sedation. A list of medication dosages are not mentioned as this is typically a practice issue that varies from institution to institution and practitioner to practitioner. Subsequently, no matter what is institutional policy, the practitioner must adhere to all national, state, and hospital guidelines when administering any IV medication. Inconsistencies between physicians’ orders and guidelines should be resolved prior to administering any medication(s). Commonly used conscious sedation medications are found in Table 2.
Dosage is extremely important and is usually calculated by the patient’s weight because an accurate weight must be obtained prior to medication administration. The physician must adhere to medication administration and monitoring guidelines. Preprocedure, intraprocedure, and postprocedure care of a child should be documented on the procedural record and on the sedation flow record. Knowledge, preparation, and clinical competency are key elements in the success of conscious sedation.
Equipment and Supplies
Prior to sedating the patient, the health care practitioner needs to assure that all monitoring equipment required for conscious sedation is present and functioning. Age-specific equipment must include: oxygen delivery devices, suction apparatus and supplies, airway management and resuscitative equipment, patient monitoring devices, intravenous access supplies, and emergency medications. All patient care equipment should also be listed in the conscious sedation procedure and maintained on a regular basis.
Since conscious sedation depresses the level of consciousness while allowing the patient to maintain their airway independently, the practitioner must focus on assessing parameters that may be impacted by sedating medications. Observation of the patient before, during, and after the period of sedation is crucial. Discrete changes in patient status are often observed before noticeable changes in vital signs and other parameters occur.
The ability to positionally maintain a patent airway should be assessed and documented by determining the level of consciousness and arousability of the patient. The baseline level of consciousness (LOC) prior to sedation should also be assessed and documented. Breathing should be assessed through the use of continuous pulse oximetry and observation of respiratory rate, depth, and effort. Circulation should be assured through blood pressure, pulse, and cardiac rhythm monitoring. Hypoxemia from any cause is often reflected by cardiac dysrhythmias (especially bradycardia), necessitating the need for continuous heart monitoring throughout the period of sedation and recovery.
Hemodynamic changes can reflect physiological alterations such as circulating volume changes, vasoconstriction, vasodilatation, and other effects of sedation and/or the accompanying procedure. In addition, an operational intravenous site should be established before the procedure as appropriate and maintained throughout the recovery period of sedation. Age-specific resuscitation equipment should also be present and staff competency verified in advanced life support that includes airway management.
The patient must be continuously monitored from the start of conscious sedation until the time discharge criteria are met. Baseline vital signs, oxygen saturation level, heart rate, rhythm, and level of consciousness are the minimum assessment parameters obtained and documented prior to sedation. The patient should be monitored at 1-2 minute intervals during the initial medication administration sequence. This may go to 5-minute intervals during the procedure. Respiratory assessment during implementation must assess chest movement, color, and auscultation of breath sounds.
Pulse oximetry (SpO2), end-tidal carbon dioxide (EtCO2), and supplemental oxygen may be used as appropriate to procedure protocol or to the patient’s condition. Recent improvements in EtCO2 sidestream technology make this a viable, noninvasive option for assessment purposes that rapidly notes respiratory response to administered medications. In addition, capnography has been clearly shown to provide the earliest warning of respiratory depression and apnea long before changes in pulse oximetry occur.8-10 The patient must be monitored by a practitioner who is not directly assisting the patient’s care procedure. This individual may assist the practitioner with interruptible tasks of short duration provided that adequate monitoring is maintained during the procedure.
The practitioner should immediately report to the physician any unexpected response by the patient. These include, but are not limited to, variations from baseline ±20% in blood pressure or pulse; cardiac dysrhythmias (continuous); Ž5% below baseline SpO2; dyspnea, apnea, or hypoventilation; diaphoresis; inability to arouse the patient; or the need to maintain the patient’s airway mechanically. Once the patient’s vital signs are at presedation levels or at least 30 minutes have passed since the last sedating medication, monitoring of physiological parameters may be increased to every 15 minutes until the patient returns to presedation level of consciousness and stability.
The practitioner should continue to monitor the patient post-procedure in 10-15 minute intervals until baseline LOC is obtained or 2 hours pass. During this 2-hour window, reversal agents may be given to the patient to relieve the effects of the medication(s) provided during the procedure. However, if the patient does not return to baseline LOC, the patient should probably be admitted for observation or monitored until the LOC has returned to a pre-procedure level. This too should be stated in the hospital’s conscious sedation policy.
During post-procedure monitoring, a scoring system is typically used to evaluate the patient’s status. This assessment tool is called the Alderete Scale.11 The scale evaluates the following patient criteria and scores them accordingly (Table 3).
Based on the patient’s post-procedure assessment, the Alderete Scale must total a score of 8 or more for the patient to be discharged. Again according to policy, if the patient does not meet this criterion in a designated time frame after the procedure, the patient should be admitted for observation and further monitoring. If a score of 8 or greater is attained, patient discharge instructions should be provided not only to the patient, but also to a caregiver who is responsible for taking the patient home. Discharge instructions should include emergency phone numbers and contacts if an emergency arises once back in the home environment. A courtesy follow-up call 24 hours post-procedure is recommended.
All procedures associated with conscious sedation should have a criteria-based measurement system and mechanism that supports documenting patient outcomes. For example, these may include procedural complications, adverse reaction to medication, delays in discharges related to medication dosing, and caregiver calls within the first 24 hours after discharge. For the hospital’s ongoing quality improvement process to be effective, this type of process must be supported, monitored, and reported on a regular basis.
As improvements continue to occur in the areas of conscious sedation medications, patient monitoring applications, and techniques, the opportunities to expand the practice of respiratory care practitioner procedures will grow exponentially. It is incumbent upon the profession in general, and hospital leadership specifically, to grasp such opportunities by actively participating and supporting multidisciplinary collaborative opportunities within their organization. By fostering these relationships, providing trained and competently verified practitioners, while demonstrating regulatory compliance and appropriate patient outcomes, the model described in the article can be utilized to further expand the quality role of the RCP at the bedside.
Gary J. Hospodar, MAOM, RRT, RCP, is employed by Kaiser-Permanente Foundation, San Francisco. The lecture “Conscious Sedation—Are We Asleep at the Wheel?” was presented at the AARC Annual Congress in Cincinnati, in October 2000.
- American Society of Anesthesiologists. Continuum of depth of sedation. Definition of general anesthesia and levels of sedation/analgesia. Approved by House of Delegates on October 13, 1999. Available at: www.asahq.org/Standards/20.htm. Accessed July 7, 2000.
- American Academy of Pediatrics Committee on Drugs. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics. 1992;89:1110-1115.
- American Academy of Pediatric Dentistry. Guidelines for the elective use of pharmacological conscious sedation and deep sedation in pediatric dental patients. Pediatric Dentistry. 1993;15:297-301.
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Anesthesia Care: Survey process. Available at: www.jcaho.org/standard/clarif/anesthesia.html. Accessed August 29, 2000.
- American Society of Anesthesiologists. Continuum of depth of sedation. Definition of general anesthesia and levels of sedation/analgesia. Approved by House of Delegates on October 13, 1999. Available at: www.asahq.org/Standards/20.htm. Accessed July 27, 2000.
- Practice guidelines for sedation and analgesia by non-anesthesiologists. A report by the American Society of Anesthesiologists Task Force on sedation and analgesia by non-anesthesiologists. Anesthesiology. 1996;84:459-471.
- Krauss B, Carroll P. Procedural sedation and analgesia. RT Magazine. 2000;13(4):31-35, 98.
- Vaghadia H, Jenkins LC, Ford RW. Comparison of end-tidal carbon-dioxide, oxygen saturation and clinical signs for the detection of oesophageal intubation. Can J Anaesth. 1989;36:560-564.
- Guggenberger H, Lenz G, Federle R. Early detection of inadvertent oesophageal intubation: pulse oximetry vs capnography. Acta Anaesthesiol Scand. 1989;33:112-115.
- Poirier MP, Gonzalez Del-Rey JA, McAneney CM, et al. Utility monitoring of capnography, pulse oximetry, and vital signs in the detection of airway mishaps: a hyperoxemic animal model. Am J Emerg Med. 1998;16:350-352.
- Alderete JA. Discharge criteria. Bailliere’s Clinical Anesthesiology. 1994;8:763-773.
- American Society of Anesthesiologists. The ASA Physical Status Classification System. Approved by House of Delegates on October 13, 1999. Available at: www.asahq.org/ProfInfo/PhysicalStatus.html. Accessed July 27, 2000.