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 Table of Contents    
SPECIAL ARTICLE
Year : 2018  |  Volume : 62  |  Issue : 7  |  Page : 493-496  

Standards of care for procedural sedation: Focus on differing perceptions among societies


Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India

Date of Web Publication11-Jul-2018

Correspondence Address:
Dr. Satyen Parida
Department of Anesthesiology and Critical Care, JIPMER, Puducherry
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ija.IJA_201_18

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Adherence to established standards of care is important for anaesthesiologists to avoid undesirable legal consequences of their actions. The judiciary lays stress on the need to perpetuate healthy doctor–patient correspondence, good documentation, and to bestow a justifiable standard of care. But what defines standard of care and who delineates such standards is something that lacks clarity. The American Society for Gastrointestinal Endoscopy (ASGE) has recently released updated guidelines on the use of sedation and anaesthesia for gastrointestinal endoscopic procedures. Almost simultaneously, the American Society of Anesthesiologists (ASA) has brought out practice guidelines for moderate sedation and analgesia. In contrast to the ASA recommendations, ASGE does not view capnography as an essential monitoring modality for endoscopic procedures with moderate sedation because it has apparently not been shown to improve patient safety. However, they do agree that evidence supports its deployment during deep sedation. These differences in views between guidelines published by societies of substantial academic and clinical standing can confuse the agreement over what constitutes standard of care for the particular speciality. It is the expectation that guidelines and consensus statements in anaesthesiology be preferably issued by national or international organizations of the same speciality.

Keywords: Capnography, endoscopy, guidelines, sedation, standard of care


How to cite this article:
Parida S, Kundra P, Mohan V K, Mishra SK. Standards of care for procedural sedation: Focus on differing perceptions among societies. Indian J Anaesth 2018;62:493-6

How to cite this URL:
Parida S, Kundra P, Mohan V K, Mishra SK. Standards of care for procedural sedation: Focus on differing perceptions among societies. Indian J Anaesth [serial online] 2018 [cited 2018 Sep 18];62:493-6. Available from: http://www.ijaweb.org/text.asp?2018/62/7/493/236445




   Introduction Top


“Standards of care” for provision of medical services by a clinician are poorly defined. It could, depending on variable perception, be defined by the evidence base, by what clinicians of identical professional stature do, by what groups of clinicians agree upon as the justifiable level of care, or by what expert panels enunciate as best practices. The American Society for Gastrointestinal Endoscopy (ASGE) has released updated 2018 guidelines on the use of sedation and anaesthesia for gastrointestinal endoscopic procedures. These guidelines have been published in the journal Gastrointestinal Endoscopy.[1] Significantly, the ASGE guidelines depart from the American Society of Anesthesiologists (ASA) guidelines on the use of capnography.[2],[3] In contrast to the ASA recommendations regarding capnography, ASGE states that integrating capnography into patient monitoring protocols for endoscopic procedures with moderate sedation has not been shown to improve patient safety. However, the ASGE does concede that there is evidence to support its use in procedures targeting deep sedation. The guidelines also recommend use of this modality of monitoring sedation during complex endoscopic procedures, patients with multiple medical comorbidities, or those at risk for airway compromise. The ASGE does, however, concur with the ASA position that sedation is a continuum ranging from minimal sedation or anxiolysis to general anaesthesia.[3] It is worth pondering over how many patients originally targeted to have moderate sedation could actually progress to deeper levels resulting in transient hypoxemia, which however, the ASGE perceives as being inconsequential, since the relationship between these events and the occurrence of serious cardiopulmonary events has not been established.

Basis of guideline recommendations

These new directions from the ASGE are representative of the problems that can crop up when guidelines, advisories, or consensus statements depend on the obtuse exposition of available evidence accrued from different sources. The ASGE guidelines base their submission on the topic, on the results of a randomized clinical trial [4] undertaken in a fairly limited and carefully chosen patient subset, the results of which are being extended to a much wider patient population, whereas the ASA guidelines for moderate sedation in 2018, which makes a strong pitch for the use of capnography, draw conclusions from a set of randomised trials [4],[5],[6],[7],[8] that also includes the one that ASGE bases its statement on.

Capnography in moderate sedation

So, should capnography be a necessary accompaniment for monitoring moderate sedation? The plane of sedation is not so easy to fix. Different patients have different sensitivities to sedative agents. There are some patients who are at a higher risk of airway obstruction/hypoventilation due to coexisting conditions even at moderate levels of sedation. Further, despite careful titration of drugs, either through target controlled infusion (TCI) or otherwise, there is always a possibility the patient can slip either way, i.e., to light sedation or deep sedation and it may take a while for the patient to get back to a level of moderate sedation following drug adjustments. The time when a patient is in deep sedation even for a few minutes can prove to be catastrophic. Meta-analysis of randomized controlled trials indicates that the use of capnography corresponds with a reduced frequency of hypoxemic events, defined as SpO2<90%, when compared to monitoring without capnography during procedures with moderate sedation.[3] However, findings for this comparison were equivocal for randomized controlled trials communicating severe hypoxemic events, defined as oxygen saturation less than 85%,[4],[5],[7] and for oxygen saturation levels of 92, 93, and 95%.[6],[8],[9],[10] However, it is eminently debatable whether avoidance of only the severe hypoxemic events should be the aim of monitoring patients undergoing moderate sedation.

The aim of monitoring is not only to identify problems and complications, but to avoid those. In the present scenario, it would be deemed inappropriate to even talk about saturation of 92% or 85%, leave alone checking if it causes cardiovascular or cerebral compromise. Monitoring EtCO2 will give early warning about the possibility of desaturation, and hence, interventions start before the patient actually desaturates.

Endoscopy is not a procedure which can be comfortably done in patients who are capable of communicating. They often require deeper planes of anaesthesia. When patients gag, or move, the tendency is to increase the dose of the drug. For upper gastrointestinal diagnostic procedures which are short, the only time patients have significant discomfort is when the scope passes through the pharynx. However, procedures like Endoscopic retrograde cholangiopancreatography (ERCP), which take more time, and more manipulation, moderate sedation at all times may not be adequate. When sedation is being given by a non-anaesthesiologist, monitored parameters should actually be more than when an anaesthesiologist does it. A person who is not professionally trained to assess respiratory movements and changes thereof might pick up problems late. And the whole purpose of monitoring during sedation is to detect problems early.

Anaesthesia guidelines from non-anaesthesiology societies

Sedation for endoscopic procedures is done by medical workers at many levels in different countries. Sedation is pursued, in certain practices, by nurses and junior doctors working under the supervision of the endoscopist. This obviously has prompted drafting of these guidelines by ASGE. It would appear, however, that the ASGE has in this case brought forth guidelines that are clearly under the purview of the science of anaesthesiology, even though the care being delivered could be by a non-anaesthesiologist. The point of contention here is certainly not the intent of the ASGE in providing clinical guidance to what appears to be non-anaesthesiology clinicians in safe provision of sedation for patients undergoing gastrointestinal endoscopic procedures. ASGE appears, in this particular recommendation about the use of end-tidal CO2, to have assumed that moderate and deep sedation are compartmentalized clinical entities, with no possibility of one proceeding to the other, a concept that most clinical anaesthesiologists would not concur with. There is no doubt that ASGE is a highly respected clinical organization. It should also be amply evident that an organization such as this, when it frames guidelines, would do so based on the recommendations of an expert panel of the highest order, who would without a doubt, undertake a punctilious perusal of the available data. However, it is apparent from the stated procedure employed for drafting these guidelines, that there was no attempt to garner opinions of other clinicians who may have a stake in development of these guidelines in any relevant clinical meetings, as is done in several other clinical societies. The strategem of the ASA for developing guidelines is, on the other hand, extremely rigorous with the 2018 guidelines on moderate sedation going through a seven-step process.[3] This includes a systematic process that clearly determines the precise level of evidence spanning across all the strata of evidence assembled.

Who determines standard of care?

This brings us back to the very important question: Who determines what is the standard of care for a medical speciality? Unfortunately, the response is not straightforward and rests to a large extent on the situation, with no clarity on who could prescribe such standards. In the Indian judicial system, since it is not easy to represent distinct standards for all facets of clinical execution and all phenomena, the courts have fashioned the “reasonable and prudent” doctor. In most judicial perceptions, the doctor must demonstrate a justifiable degree of skill and mastery over his science and must exercise an equitable degree of care, neither of which need necessarily, be of the highest standards. Despite disclaimers by societies which bring out guidelines such as the one under consideration, that these should not be construed as legal standards of care, doubts can arise when the practising doctor in an area does not follow a clinical execution guideline that is well-documented.

Guidelines galore

There are currently many institutions, societies, and groups which are coming out with communications, guidelines, and frameworks for anaesthetic applications. The trend needs to be discouraged. First, it is often evident that small groups funded either directly or indirectly by pharmaceutical agencies are often not of the levels desired to bestow guidelines, practice parameters, or consensus statements, notwithstanding the credentials of the experts in the group. It is imperative that issuing guidelines, practice parameters, or consensus statements should be undertaken only by the population germane to that medical speciality. For anaesthesiology, for instance, this should involve national and international societies devoted to anaesthesiology as a whole, or national and international societies constantly related to the sub-specialities thereof, since these institutions would have the necessary number of clinicians to appropriately fund criterion buildout, and their summits would have the requisite delegates to review the parameters proposed during open conventions.

Summary

Well-organized testing of distinct society advocacies is a must. It is imperative that these advocacies in any consensus statements be revoked by new authentication in scientific literature. It is also essential that groups and institutions without a rigorous strategy and/or extremely high levels of credibility for drafting these guidelines should leave the compilation of consensus statements, parameters, and practice guidelines to others with ample resources and adherents to appropriately draft and review those.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
ASGE Standards of Practice Committee. Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2018;87:327-37.  Back to cited text no. 1
    
2.
Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-17.  Back to cited text no. 2
    
3.
Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia. Anesthesiology 2018;128:437-79.  Back to cited text no. 3
    
4.
Mehta PP, Kochhar G, Albeldawi M, Kirsh B, Rizk M, Putka B, et al. Capnographic monitoring in routine EGD and colonoscopy with moderate sedation: A prospective, randomized, controlled trial. Am J Gastroenterol 2016;111:395-404.  Back to cited text no. 4
    
5.
Beitz A, Riphaus A, Meining A, Kronshage T, Geist C, Wagenpfeil S, et al. Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: A randomized, controlled study (ColoCap Study). Am J Gastroenterol 2012;107:1205-12.  Back to cited text no. 5
    
6.
Langhan ML, Shabanova V, Li FY, Bernstein SL, Shapiro ED. A randomized controlled trial of capnography during sedation in a pediatric emergency setting. Am J Emerg Med 2015;33:25-30.  Back to cited text no. 6
    
7.
Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, et al. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology 2009;136:1568-76.  Back to cited text no. 7
    
8.
Slagelse C, Vilmann P, Hornslet P, Jørgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: A randomized study. Scand J Gastroenterol 2013;48:1222-30.  Back to cited text no. 8
    
9.
Deitch K, Miner J, Chudnofsky CR, Dominici P, Latta D: Does end tidal CO2 monitoring during emergency department procedural sedation and analgesia with propofol decrease the incidence of hypoxic events?: A randomized, controlled trial. Ann Emerg Med 2010;55:258-64.  Back to cited text no. 9
    
10.
Lightdale JR, Goldmann DA, Feldman HA, Newburg AR, DiNardo JA, Fox VL. Microstream capnography improves patient monitoring during moderate sedation: A randomized, controlled trial. Pediatrics 2006;117:e1170-8.  Back to cited text no. 10
    




 

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