TY - JOUR
T1 - Patient safety during sedation by anesthesia professionals during routine upper endoscopy and colonoscopy
T2 - an analysis of 1.38 million procedures
AU - Vargo, John J.
AU - Niklewski, Paul J.
AU - Williams, J. Lucas
AU - Martin, James F.
AU - Faigel, Douglas O.
N1 - Funding Information:
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: P. J. Niklewski, J. F. Martin: employees and developers of the SEDASYS System, Ethicon, Endo-Surgery Inc. All other authors disclosed no financial relationships relevant to this publication. P. J. Niklewski and J. F. Martin received research support as they were employed by Ethicon. J. L. Williams was paid by CORI, which received funding from Ethicon. Drs Vargo and Faigel received no funding support.
Publisher Copyright:
© 2017 American Society for Gastrointestinal Endoscopy
PY - 2017/1/1
Y1 - 2017/1/1
N2 - Background and Aims Sedation for GI endoscopy directed by anesthesia professionals (ADS) is used with the intention of improving throughput and patient satisfaction. However, data on its safety are sparse because of the lack of adequately powered, randomized controlled trials comparing it with endoscopist-directed sedation (EDS). This study was intended to determine whether ADS provides a safety advantage when compared with EDS for EGD and colonoscopy. Methods This retrospective, nonrandomized, observational cohort study used the Clinical Outcomes Research Initiative National Endoscopic Database, a network of 84 sites in the United States composed of academic, community, health maintenance organization, military, and Veterans Affairs practices. Serious adverse events (SAEs) were defined as any event requiring administration of cardiopulmonary resuscitation, hospital or emergency department admission, administration of rescue/reversal medication, emergency surgery, procedure termination because of an adverse event, intraprocedural adverse events requiring intervention, or blood transfusion. Results There were 1,388,235 patients in this study that included 880,182 colonoscopy procedures (21% ADS) and 508,053 EGD procedures (23% ADS) between 2002 and 2013. When compared with EDS, the propensity-adjusted SAE risk for patients receiving ADS was similar for colonoscopy (OR,. 93; 95% CI,. 82-1.06) but higher for EGD (OR, 1.33; 95% CI, 1.18-1.50). Additionally, with further stratification by American Society of Anesthesiologists (ASA) class, the use of ADS was associated with a higher SAE risk for ASA I/II and ASA III subjects undergoing EGD and showed no difference for either group undergoing colonoscopy. The sample size was not sufficient to make a conclusion regarding ASA IV/V patients. Conclusions Within the confines of the SAE definitions used, use of anesthesia professionals does not appear to bring a safety benefit to patients receiving colonoscopy and is associated with an increased SAE risk for ASA I, II, and III patients undergoing EGD.
AB - Background and Aims Sedation for GI endoscopy directed by anesthesia professionals (ADS) is used with the intention of improving throughput and patient satisfaction. However, data on its safety are sparse because of the lack of adequately powered, randomized controlled trials comparing it with endoscopist-directed sedation (EDS). This study was intended to determine whether ADS provides a safety advantage when compared with EDS for EGD and colonoscopy. Methods This retrospective, nonrandomized, observational cohort study used the Clinical Outcomes Research Initiative National Endoscopic Database, a network of 84 sites in the United States composed of academic, community, health maintenance organization, military, and Veterans Affairs practices. Serious adverse events (SAEs) were defined as any event requiring administration of cardiopulmonary resuscitation, hospital or emergency department admission, administration of rescue/reversal medication, emergency surgery, procedure termination because of an adverse event, intraprocedural adverse events requiring intervention, or blood transfusion. Results There were 1,388,235 patients in this study that included 880,182 colonoscopy procedures (21% ADS) and 508,053 EGD procedures (23% ADS) between 2002 and 2013. When compared with EDS, the propensity-adjusted SAE risk for patients receiving ADS was similar for colonoscopy (OR,. 93; 95% CI,. 82-1.06) but higher for EGD (OR, 1.33; 95% CI, 1.18-1.50). Additionally, with further stratification by American Society of Anesthesiologists (ASA) class, the use of ADS was associated with a higher SAE risk for ASA I/II and ASA III subjects undergoing EGD and showed no difference for either group undergoing colonoscopy. The sample size was not sufficient to make a conclusion regarding ASA IV/V patients. Conclusions Within the confines of the SAE definitions used, use of anesthesia professionals does not appear to bring a safety benefit to patients receiving colonoscopy and is associated with an increased SAE risk for ASA I, II, and III patients undergoing EGD.
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U2 - 10.1016/j.gie.2016.02.007
DO - 10.1016/j.gie.2016.02.007
M3 - Article
C2 - 26905938
AN - SCOPUS:84961842236
SN - 0016-5107
VL - 85
SP - 101
EP - 108
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 1
ER -