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Multisociety Sedation Curriculum for Gastrointestinal Endoscopy

2012; Elsevier BV; Volume: 143; Issue: 1 Linguagem: Inglês

10.1053/j.gastro.2012.05.001

1528-0012

John J. Vargo, Mark H. DeLegge, Andrew D. Feld, Patrick D. Gerstenberger, Paul Y. Kwo, Jenifer R. Lightdale, Susan Nuccio, Douglas K. Rex, Lawrence R. Schiller,

Airway Management and Intubation Techniques

Podcast interview: www.gastro.org/gastropodcast. Also available on iTunes. Podcast interview: www.gastro.org/gastropodcast. Also available on iTunes. Introduction—VargoSedation Pharmacology—DeLeggeInformed Consent for Endoscopic Sedation—FeldPeriprocedure Assessment for Endoscopic Procedures—KwoLevels of Sedation—LightdaleTraining in the Administration of Specific Agents for Moderate Sedation—GerstenbergerTraining in Airway/Rescue Techniques and Management of Complications—RexAnesthesiologist Assistance for Endoscopic Procedures—VargoIntraprocedure Monitoring—NuccioPostprocedure Assessment Training—VargoEndoscopy in Pregnant and Lactating Women—VargoAssessment of Competency in Endoscopic Sedation—SchillerBibliographyAppendix: Primer in Sedation Pharmacology—DeLegge The Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE) grew out of the need for a complete and programmatic approach to the training of procedure sedation. As a natural outgrowth of the Gastroenterology Core Curriculum, the sponsoring societies thought that a comprehensive document covering the aspects of procedure sedation from pharmacology, periprocedure assessment, airway management, and the use of anesthesia services was necessary for a variety of reasons. Chief among these was to ensure a standardized basis for instruction through the use of competency-based training. This constitutes a living document that represents the sponsoring societies' vision of best practices in procedure sedation training based on published data and expert consensus. It provides a framework for developing an individual plan of study and growth that should be tailored to meet the needs of each individual trainee based on the strengths and special qualities of each individual training program. Additionally, the curriculum can serve the practicing gastroenterologist in the updating of both knowledge and skills. The curriculum will continue to evolve with time as new knowledge, methods of learning, novel techniques and technologies, and challenges arise. This edition has been divided into an overview of training and 11 sections encompassing the breadth of knowledge and skills required for the practice of procedural sedation for GI endoscopy. This MSCGE represents a joint collaborative effort among the national gastroenterology societies—the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the American Gastroenterological Association Institute, and the American Society for Gastrointestinal Endoscopy. In addition, the Society for Gastroenterology Nurses and Associates played a crucial role in the development of the MSCGE. Other professional non-GI societies and regulatory organizations were invited to take part in the development of the MSCGE. This included the American Association of Nurse Anesthetists, the American Society of Anesthesiologists (ASA), and the Centers for Medicare and Medicaid Services (CMS). The American Association of Nurse Anesthetists did not respond to inquiries, CMS decided not to participate, and the ASA appointed a nonvoting observer who participated in the developmental process. The executive committees of each of the sponsoring societies, as well as several subject matter experts, made specific recommendations for revising the core curriculum. Each society then named representatives who were charged with overall responsibility for developing, communicating, and distributing the curriculum. Throughout this document, the paramount importance of practice and research based on the highest principles of ethics, humanism, and professionalism is reinforced. Endoscopic sedation strives to seek a balance between patient comfort and drug-related side effects. Optimal sedation allows the patient the greatest degree of comfort while preserving the greatest degree of safety. To achieve this, the endoscopist must fully understand the sedation that he or she is are using. This also requires careful consideration of the patient, the endoscopy facility, and the variables of the procedure itself. Patient factors include age, weight, medical history, concurrent medications, intubation assessment, preprocedure anxiety, and pain tolerance. Procedure variables include the amount of anticipated discomfort, the duration of examination, and how invasive the procedure will be. The drugs most widely used for endoscopic sedation were the benzodiazepines and opioids. Recently, there has been growing interest in the use of other agents with unique pharmacologic properties designed to enhance sedation and analgesia. The endoscopist should be familiar with the sedation agents used including the drug's pharmacokinetic parameters (time of onset, peak response, and duration of effect), pharmacodynamic profile (individual variations in clinical response to a drug), elimination profile, potential adverse effects, and drug-drug interactions. Trainees should gain an understanding of the following:1The pharmacokinetics and pharmacodynamics of different sedation agents, their synergy and potential interactions with other medications and potential adverse reactions.2Mastery of the titration of these agents for the desired level of sedation. For the vast majority of endoscopic cases, this should be moderate sedation. 1Trainees should develop a thorough knowledge of the pharmacokinetics and pharmacodynamics of sedation agents before embarking on endoscopic training.2Trainees should develop expertise in the administration of sedation medications under direct supervision in the endoscopy suite. If a high-fidelity sedation simulator is available, this should be used before training in the endoscopy suite. A brief primer in sedation pharmacology is provided in Appendix A. Knowledge of sedation pharmacology should be assessed as part of the overall evaluation of trainees in gastroenterology during the fellowship. Questions relating to sedation pharmacology should be included on the board examination and should reflect a general knowledge of this content. The ethical and legal requirement to obtain informed consent before performing endoscopy derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure and understanding those risks and the benefits and alternative approaches, makes a voluntary and uncoerced informed decision to proceed. The process of obtaining informed consent is both a basic ethical obligation and also a legal requirement for physicians. It allows the patient to gain an understanding of the proposed treatment and the risks involved, as well as learn about alternatives or voice any concerns or questions. The physician has the opportunity to ask about the patient's treatment goals and discover any patient-specific information that will enable the most optimal choice of treatment. When an informed patient agrees to proceed with a course of treatment, this allows substantial transfer of the risk of adverse outcome to the patient who understands and accepts the imperfect nature of the procedure and therapy. Most state laws specify that obtaining informed consent is a nondelegatable duty, ie, it must be performed by the physician and cannot be relegated to one's staff or endoscopy nurse. However, consent is a process, and if sufficient and thorough information is provided, the final portion, in which the physician finalizes consent before the procedure and asks the patient whether there are any other questions remaining, may be very brief. This is most important for the success of an open-access process, so that open-access patients have already received information and have been given the opportunity to ask questions to satisfaction before preparation for the procedure. Language issues need to be addressed by using an interpreter. If the patient is unable to give consent, an appropriate legal representative should be sought. A risk management recommendation particularly relevant for informed consent for open access is to have an intake/preparation process for open access in which the patient is sent or verbally given information about the procedure, including the purpose, description of the procedure, and risks, benefits, and alternatives. It would be useful to instruct the patient to call in if any concerns or questions occur after having read the information and document this instruction. Further, one could instruct the office staff to be alert to patients who appear uncertain, seem to have many questions, or very worried about proceeding; these patients may be best served with a preprocedure consultation. At the time of the open access, the physician can meet state law obligation by briefly summarizing the information. The nature of moderate sedation is such that a patient may perceive, but may not be aware of the context and surroundings to sufficiently understand the implications of a demand to stop the procedure. The discomfort is likely to be short-lived and the procedure safe and successful, and often the patient has no recall of difficulty or any request to stop the procedure. Additional medication or additional techniques may allow more comfortable completion of the procedure. Indeed, the patient may wish the discomfort to stop, not the procedure! However, the endoscopist and staff must be aware that consent can be withdrawn. The author surmises, based on conversations with experienced endoscopists, that most requests to stop are not truly withdrawal of consent, but an artifact of sedation causing misperception of the context of procedure activity. However, the prudent endoscopist will carefully evaluate a request to stop, assessing, for example, whether the patient is speaking in full coherent sentences or mumbling incomprehensibly, to be as certain as possible that it is not a true withdrawal of consent. During training, the trainee should gain an understanding of the following:IThe principles of informed consentACapacity to give consentBMaterial risks of endoscopic sedationCShared decision making1Discussion of sedation alternatives, from no sedation to anesthesiologist-provided general deep sedation.DExemptions for the consent requirement1Emergency exception/waiverEWithdrawal of consentFRegulatory and institutional requirements to obtain and document consentIIUnderstand that informed consent includes endoscopic sedation as well as endoscopic procedures, ie, it applies to the sedation portion of the global procedure experienceIIIUnderstand the special situations and considerations, such as the applications of informed consent in an open-access settingIVUnderstand shared decision-making conceptsVUnderstand the concept of withdrawal of consentAAn ineffectively sedated patient has the right to demand that the procedure be stopped, even though partially sedated.BBe aware of risk factors for ineffective sedation, which may prompt withdrawal of consent in a patient expecting significant sedation. These include chronic narcotic and/or anxiolytic use with patients in whom anxiolytic/narcotic sedation is planned and medical conditions that may preclude effective sedation, such as chronic obstructive pulmonary disease, cor pulmonale, advanced cardiomyopathy, and severe obstructive sleep apnea.VIGive the patient the opportunity to ask questions. A short training process will likely be sufficient because most trainees will already have a basic understanding of informed consent. Targeted review and training for endoscopic sedation may include reading materials and/or lecture(s) and/or direct observation of faculty with discussion by faculty. Adequacy of learning may be assessed by written examination and/or oral discussion with faculty and/or observation by faculty. Periprocedure assessment is a crucial component of the practice of endoscopic sedation. Preprocedure assessment should encompass a thorough review of the patient's sedation history, the identification of medical conditions that may increase the risk of procedure sedation, and balance these findings with the type of procedure scheduled and the targeted level of sedation. Intraprocedure assessment encompasses the maintenance of stable and safe cardiovascular parameters and level of sedation. The postprocedure assessment focuses on ensuring the recovery of baseline physiologic parameters and the identification of any complications. The trainees should be competent in the periprocedure assessment of the patients undergoing sedation for all GI endoscopic procedures. During fellowship, trainees should obtain a comprehensive understanding of the following during the preprocedure evaluation of patients undergoing endoscopic procedures with sedation:1Confirm the patient's suitability to undergo the planned procedure at the targeted sedation level (Table 1).Table 1ASA Physical Status ClassificationPS 1Normal healthy patientNo organic, physiologic, or psychiatric disturbance; excludes the very young and very old; healthy with good exercise tolerancePS 2Patients with mild systemic diseaseNo functional limitations; has a well-controlled disease of 1 body system; controlled hypertension or diabetes without systemic effects, cigarette smoking without COPD; mild obesity, pregnancyPS 3Patients with severe systemic diseaseSome functional limitation; has a controlled disease of >1 body system or 1 major system; no immediate danger of death; controlled CHF, stable angina, previous heart attack, poorly controlled hypertension, morbid obesity, chronic renal failure; bronchospastic disease with intermittent symptomsPS 4Patients with severe systemic disease that is a constant threat to lifeHas at least 1 severe disease that is poorly controlled or at end stage; possible risk of death; unstable angina, symptomatic COPD, symptomatic CHF, hepatorenal failurePS 5Moribund patients who are not expected to survive without the operationNot expected to survive >24 h without surgery; imminent risk of death; multiorgan failure, sepsis syndrome with hemodynamic instability, hypothermia, poorly controlled coagulopathyPS 6A declared brain-dead patient who organs are being removed for donor purposesASA, American Society of Anesthesiologists; PS, physical status; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure. Open table in a new tab 2The trainee will obtain a directed history that addresses the potential influence on the procedure and the anticipated level of sedation with particular attention to the following:aCardiopulmonary disease (ischemic heart disease, congestive heart failure, asthma, chronic obstructive pulmonary disease). Assessment for obstructive sleep apnea, stridor, neurologic, or seizure disorders. Previous experience with procedural sedation should also be queried.bA complete list of medications, including over-the-counter agents, and allergies should be recorded.cThe patient should be assessed according to the ASA physical status classification scale (Table 1).3Trainees will gain knowledge about the role of moderate sedation in ASA classes 1 through 3.4Trainees must ascertain the duration of fasting before a procedure, ie, 2 hours after clear liquid intake and 6 hours after a light meal before sedation to allow administration of moderate sedation or anesthesiologist-directed sedation. These intervals should be lengthened in the setting of gastric-emptying abnormalities.5The trainee will perform a targeted physical examination, including vital signs with heart rate, blood pressure, and baseline oxygen saturation. The patient should have a cardiopulmonary assessment to screen for stridor, wheezing, heart murmurs or arrhythmias, as well as an abdominal examination for surgical scars and masses. A limited neurologic examination should assess presedation mental status orientation to assess for obvious focal deficits. Finally, a detailed evaluation of the airway, including body habitus, neck structure, cervical spine, hyoid mental distance, and oropharynx, should be performed.6Trainees should gain knowledge about periprocedure endoscopic sedation in special circumstances, such as pregnancy. Trainees should clearly document the patient's preanesthesia assessment history, physical examination, and informed consent. Before administration of anesthesia, a time out should be performed according to the Joint Commission's Universal Protocol and should include, at a minimum, the procedure team's agreement as to the patient's identity and the type of procedure to be performed. ASA, American Society of Anesthesiologists; PS, physical status; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure. Procedure assessment for endoscopic procedures should be assessed as part of the overall evaluation of trainees in gastroenterology during fellowship. Questions relating to procedure assessment should be included on the board examination and should reflect a general knowledge of this content. In recent years, the Joint Commission has identified the following 4 levels of sedation, which stretch along a continuum without clear boundaries: minimal sedation or anxiolysis, moderate sedation, deep sedation, and general anesthesia. To date, these levels of sedation have been defined by a patient's response to verbal, light tactile, or painful stimuli, although they are generally also associated with physiologic changes in patient vital signs. Viewed from the perspective of a continuum of sedation, targeting minimal levels of sedation by definition creates the potential for patients to become deeply sedated. Accordingly, it has been recommended that all providers be prepared to rescue patients from deeper levels of sedation than targeted. It should be noted that there are no physiologic data to support these definitions. Most cardiopulmonary events during GI endoscopy stem from hypoventilation cascading into hypoxia and cardiac decompensation. As a basic component of monitoring, pulse oximetry has become a standard of care in endoscopy units around the world. Yet, pulse oximetry may not adequately reflect hypoventilation, apnea, impending hemodynamic instability, or vasoconstrictive shock. In particular, patients may be well saturated with oxygen and still experience significant carbon dioxide retention. Technological advances in the past decade have enabled the practical measurement of real-time end-tidal carbon dioxide and ventilatory waveforms in nonintubated patients. In this way, capnography has emerged as a noninvasive way of measuring patient ventilation that may be especially useful in patients undergoing deeper levels of sedation. Consensus also dictates that levels of sedation are directly related to patient risks. Minimal sedation implies the retention of a patient's ability to respond voluntarily to vocal commands (eg, "take a deep breath" or "turn on your back") and to maintain a patent airway with protective reflexes. Moderate sedation describes a depth of sedation at which patients are able to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function, protective airway reflexes, and the ability to react to verbal or tactile stimulation. Deep sedation implies a medically controlled state of depressed consciousness from which the patient is not easily aroused, but can respond purposefully to painful stimulation. General anesthesia describes the deepest level of sedation wherein the patient is unarousable with painful stimuli. Generally speaking, depth of sedation is directly related to cardiovascular and airway instability; the deeper the level of sedation, the more a patient is considered to be at risk of cardiopulmonary events (Table 2). Monitored anesthesia care may include varying levels of sedation, analgesia, and anxiolysis as necessary.Table 2Ramsay Sedation ScaleResponse to verbal stimulationNumerical scoreAgitated6Responds readily to name spoken in normal tone5Lethargic response to name spoken in normal tone4Responds only after name called loudly and/or repeatedly3Responds only after mild prodding or shaking2Does not respond after mild prodding or shaking1Does not respond to test stimulus0 Open table in a new tab Trainees in endoscopic sedation should gain an understanding of the following:1The concept of sedation depth as a continuum2Definitions (stimulus and effect) of the 4 codified levels of sedation and expected physiologic changes in vital signs for each3Clinical training in targeting appropriate levels of sedation for patients and/or procedures4Patient and/or procedure factors that may affect the depth of sedation targeted and/or achieved5Clinical training in assessing levels of sedation continuously throughout a procedure6The difference between oxygenation and ventilation, as well how these physiologic processes are reflected by various patient monitors7Indications for advanced clinical monitoring during endoscopic procedures, including capnography Training should take place within the framework of clinical care and problem solving. Successful programs require skilled and experienced endoscopic instructors who continually maintain and improve the instructional talents required to teach endoscopy and the periprocedure assessment that is crucial to the performance of such procedures. A structured training experience coupled with ongoing evaluation of trainees' progress should be used. Knowledge of periprocedure assessment should be assessed as part of the overall evaluation of trainees in gastroenterology during the Fellowship program. Questions relating to periprocedure assessment should be included in the board examination and should reflect a general knowledge of this content. The safe and effective administration of pharmacologic agents to induce and maintain a state of moderate sedation is a core skill essential to the performance of GI endoscopic procedures. All trainees should receive comprehensive instruction in the selection and administration of agents used for moderate sedation. Although moderate sedation for endoscopic procedures is most often achieved through the intravenous bolus delivery of opioids and benzodiazepines, trainees should understand that moderate sedation may also be induced and maintained with combination regimens using propofol. Although propofol used in combination with other agents is a valuable option for moderate sedation, deep sedation generally results when it is administered as a single agent for endoscopic sedation. Trainees should recognize that deep sedation may also result from conventional sedation techniques using only opioids and benzodiazepines even when moderate sedation is targeted. As the use of propofol has rapidly expanded across the spectrum of endoscopic sedation and anesthesia, the specific manner in which it is used, including bolus or continuous-infusion dosing schemes, whether it is used in combination with adjunctive sedating and analgesic agents, and the type of health care provider (registered nurse, nurse anesthetist, physician endoscopist, anesthesiologist, nonanesthesiologist physician) who administers or supervises its use has varied widely in the United States and around the world. This variation is attributable to differing institutional history and professional culture, legal and regulatory requirements, issues of training and credentialing, and economic factors. Endoscopists who do not personally administer propofol or direct its use must still be prepared to make decisions when propofol-mediated sedation by an anesthesia provider is appropriate. They must be skilled in the recognition of delayed propofol-related adverse events that may arise after recovery from sedation, such as fever, chills, or myalgia that may arise within 48 hours of administration. In many states, a certified registered nurse anesthetist must be supervised by the physician endoscopist if the certified registered nurse anesthetist is not otherwise supervised by an anesthesiologist. Endoscopists may also assume responsibility at a managerial or ownership level for the development, approval, and monitoring of policies and procedures defining how propofol is procured, stored, administered, and accounted for in their units. The technique of titrating propofol to a level of moderate sedation after low presedation doses of an opioid, benzodiazepine, or both is known as balanced propofol sedation, which is a form of nonanesthesiologist-administered propofol sedation. Moderate sedation using propofol may also be achieved using a computer-assisted personalized sedation system known as SEDASYS, which at this time is experimental though has been granted "approvable" status by the U.S. Food and Drug Administration. Although moderate sedation, during which the patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation, is an appropriate target level of sedation for most endoscopic procedures, deep sedation, during which the patient is not easily arousable but is purposely responsive after repeated or painful stimulation, should be anticipated when patient-related or procedure-related factors suggest that moderate sedation may be inadequate. The trainee must be familiar with these factors and must recognize that transient deep sedation at some time during endoscopic procedures is a frequent outcome of conventional sedation using benzodiazepines and opioids, even when these agents are specifically titrated with the intent of maintaining moderate sedation. Although unintended periods of deep sedation may occur when moderate sedation is targeted, the planned targeting of deep sedation raises specific regulatory concerns in addition to requiring a higher level of competency in rescue techniques. The CMS has defined moderate sedation, as described previously, to be outside the scope of anesthesia services and thus exempt from the facility requirements to which hospitals are subject when anesthesia is provided. In contrast, targeted deep sedation or general anesthesia requires elements of the preanesthesia and postanesthesia evaluations that must be documented in the medical record and require that these evaluations and the anesthesia care itself be provided only by individuals who are qualified under statute §482.52(a) to administer anesthesia. Deep sedation, in contrast to moderate sedation, is currently viewed by the CMS to be a form of anesthesia (monitored anesthesia care), and thus deep sedation is subject to the statutory requirements that are applicable to anesthesia services in general. The selection and dosing of sedation agents must reflect an understanding of key principles of endoscopic sedation.1An individual patient's response to each sedation agent is unique. Response may be related to age, weight, and pharmacologic profile as well as unpredictable and unidentified factors. This patient-specific unique response necessitates careful titration to effect and to the procedure needs rather than strict adherence to standard dosing regimens.2Accumulation of drug effect occurs with repeated dosing, necessitating an understanding and consideration of time to onset of action, time to peak action, and the half-life of action for each agent used.3Synergism of drug effect occurs among sedating agents, necessitating appropriate dose reductions.4Levels of stimulation during the course of endoscopic procedures may vary markedly, potentially necessitating related adjustments to the depth of sedation during the procedure. Anticipation of periods of increased noxious stimulation allows anticipatory strategic dosing schemes, particularly if propofol is used in the balanced moderate sedation model. During a fellowship, trainees should gain an understanding of the following:1Appropriate selection of patients for moderate sedation based on findings from personal consultation and consideration ofaThe nature of the intended procedurebComorbiditiescAirway factors and other physical factors potentially affecting the sedation processdPharmacologic profileeHistory of illicit drug or alcohol usefPsychiatric profilegSedation/anesthesia history (including intolerance or potential allergy to any of the planned drugs)hPatient expectations and consent issues relating specifically to the sedation process2Pharmacologic profiles of drugs used for endoscopic sedation (see Sedation pharmacology section and Table 3)Table 3Pharmacologic Profile of Drugs Used for Endoscopic Sedation⁎For healthy individual <60 years of age.DrugOnset of action, minPeak effect, minDuration of effect, minInitial dosePharmacologic antagonistSide effectsDexemedetomidine, μg 24025-50NoneDizziness, prolonged sedationDroperidol, mg3-1030120-2401.25-2.5NoneQT interval prolongation, ventricular arrhythmia, extrapyramidal effectsFentanyl, μg1-23-530-6050-100NaloxoneRespiratory depression, vomitingFlumazenil, mg1-23600.1-0.3Agitation, withdrawal symptomsKetamine, mg 12012.5-25NoneRespiratory depression,hypotension, extrapyramidal effectsPropofol, mg<11-24-810-40NoneRespiratory depression, cardiovascular instabilityMAOI, Monoamine oxidase inhibitor. For healthy individual <60 years of age. Open table in a new tab 3Dosing regimens for induction and maintenance of moderate sedation that reflect consideration of age, weight, a