ORIGINAL ARTICLE
Safety of Gastrointestinal Endoscopy With Conscious Sedation in Patients With and Without Obstructive Sleep Apnea Christian M. Andrade, MD,*w Brijesh Patel, MD,*w Jeffrey Gill, MD,* Donald Amodeo, MD,* Prasad Kulkarni, MD,* Susan Goldsmith, MD,* Barbara Bachman, MD,* Reynaldo Geerken, MD,* Malcolm Klein, MD,*w William Anderson, MD,*w Branko Miladinovic, PhD,w Ileana Fernandez, MSN, RN,* Ambuj Kumar, MD, MPH,w Joel Richter, MD, FACP, MACG,w and Gitanjali Vidyarthi, MD*
Background and Study Aims: Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for cardiopulmonary complications. The aim of the present study was to evaluate the safety of conscious sedation in patients with OSA undergoing gastrointestinal endoscopy. Patients and Methods: This is an IRB-approved prospective cohort study performed at the James A. Haley VA. A total of 248 patients with confirmed moderate or severe OSA by polysomnography and 252 patients without OSA were enrolled. Cardiopulmonary variables such as heart rate, blood pressure, and level of blood oxygen saturation were recorded at 3-minute intervals throughout the endoscopic procedure. Results: In total, 302 colonoscopies, 119 esophagogastroduodenoscopies, 6 flexible sigmoidoscopies, and 60 esophagogastroduodenoscopy/colonoscopies were performed. None of the patients in the study required endotracheal intubation, pharmacologic reversal, or experienced an adverse outcome as a result of changes in blood pressure, heart rate, or blood oxygen saturation. There were no significant differences in the rate of tachycardia (P = 0.749), bradycardia (P = 0.438), hypotension (systolic/diastolic, P = 0.460; mean arterial pressure, P = 0.571), or hypoxia (P = 0.787) between groups. The average length of time spent in each procedure and the average dose of sedation administered also did not differ significantly between the groups. Conclusions: Despite the presumed increased risk of cardiopulmonary complications, patients with OSA who undergo endoscopy with conscious sedation have clinically insignificant variations in cardiopulmonary parameters that do not differ from those without OSA. Costly preventative measures in patients with OSA are not warranted. Key Words: conscious sedation, obstructive sleep apnea, endoscopy, complications, safety
(J Clin Gastroenterol 2016;50:198–201)
Received for publication October 23, 2014; accepted January 28, 2015. From the *Department of Gastroenterology, The James A. Haley Veterans Affairs Hospital; and wDivision of Digestive Diseases and Nutrition, University of South Florida, Tampa, FL. The authors declare that they have nothing to disclose. Reprints: Christian M. Andrade, MD, Division of Digestive Diseases and Nutrition, University of South Florida Morsani College of Medicine, 12901 Bruce B. Downs Blvd, MDC 72, Tampa, FL 33612 (e-mail: [email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
E
ndoscopy is the preferred means for diagnosis and treatment of many acute and chronic gastrointestinal disorders. Adverse events are rare with an approximate 0.1% adverse event rate for upper gastrointestinal endoscopy and 0.2% adverse event rate for lower gastrointestinal interventions.1–4 During endoscopy, cardiopulmonary changes are commonly noted,5–7 and the majority of the complications are attributed to sedation.8,9 Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for complications, especially for cardiopulmonary complications. Recent studies suggest that this concern may be exaggerated,10–14 but conclusions have been limited by small sample size, retrospective analysis, and/or failure to include patients with documented OSA by polysomnography (Table 1). In the veteran population, where OSA is an increasingly common disorder, patients are at times denied endoscopy or endoscopy is performed at a higher level of care, thus incurring substantial health care costs. Given the lack of prospective randomized trials to support this practice, these preventative measures are controversial and unsubstantiated. The aim of the present study is to prospectively evaluate the safety of conscious sedation in veterans with documented OSA by polysomnography undergoing gastrointestinal endoscopy as compared with non-OSA patients.
PATIENTS AND METHODS After IRB approval, a total of 500 patients scheduled to undergo gastrointestinal endoscopy at the James A. Haley VA Hospital signed an informed consent. The enrollment period for this prospective cohort study was from July 27, 2011 to October 22, 2013. All patients at the James A. Haley VA scheduled to undergo an endoscopic procedure with OSA were eligible for enrollment. The exclusion criteria were age below 18 years, pregnancy, mild OSA, and patients scheduled with monitored anesthesia care (MAC). In total, 248 patients with confirmed moderate or severe OSA and 252 patients without OSA were enrolled. After enrollment and data collection, all emergency department (ED) and clinic visits documented in the James A. Haley VA Computerized Patient Record System (CPRS) up to 30 days postprocedure were reviewed for possible procedurerelated complications among patients with OSA. Only those patients with the diagnoses of moderate or severe OSA as measured by the gold standard, polysomnography, were enrolled. The diagnosis of moderate or
198 | www.jcge.com J Clin Gastroenterol Volume 50, Number 3, March 2016 Copyright r 2016 Wolters Kluwer Health, Inc. All rights reserved.
J Clin Gastroenterol
Volume 50, Number 3, March 2016
Safety of Conscious Sedation in Patients With OSA
TABLE 1. Comparative Studies Regarding the Safety of Endoscopy With Conscious Sedation in Patients With OSA
N
Design
OSA Definition
O2 Sat
HR
BP
Time
Mean Sedation Dose
Cha et al10 Mador et al11 Mador et al12
96 639 904
Prospective Retrospective Prospective
NS NS NS
NS NS NS
NS NS NS
— — NS
SD NS NS
Gill et al13 Khiani et al14 This study
400 233 487
Retrospective Prospective Prospective
PSG PSG Berlin & STOP-BANG Questionnaires PSG Berlin Questionnaire PSG
— NS NS
— — NS
— — NS
— — NS
+ NS NS
References
— indicates not evaluated; + , data reported as means; BP, blood pressure; HR, heart rate; NS, not significant; OSA, obstructive sleep apnea; PSG, polysomnography; SD, significant difference.
severe OSA was confirmed by the study staff after review of an overnight polysomnography result, which was performed utilizing standard protocol as per recommended guidelines by the American Academy of Sleep Medicine.15 Apnea was defined as an airflow reduction to
Safety of Gastrointestinal Endoscopy With Conscious Sedation in Patients With and Without Obstructive Sleep Apnea Christian M. Andrade, MD,*w Brijesh Patel, MD,*w Jeffrey Gill, MD,* Donald Amodeo, MD,* Prasad Kulkarni, MD,* Susan Goldsmith, MD,* Barbara Bachman, MD,* Reynaldo Geerken, MD,* Malcolm Klein, MD,*w William Anderson, MD,*w Branko Miladinovic, PhD,w Ileana Fernandez, MSN, RN,* Ambuj Kumar, MD, MPH,w Joel Richter, MD, FACP, MACG,w and Gitanjali Vidyarthi, MD*
Background and Study Aims: Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for cardiopulmonary complications. The aim of the present study was to evaluate the safety of conscious sedation in patients with OSA undergoing gastrointestinal endoscopy. Patients and Methods: This is an IRB-approved prospective cohort study performed at the James A. Haley VA. A total of 248 patients with confirmed moderate or severe OSA by polysomnography and 252 patients without OSA were enrolled. Cardiopulmonary variables such as heart rate, blood pressure, and level of blood oxygen saturation were recorded at 3-minute intervals throughout the endoscopic procedure. Results: In total, 302 colonoscopies, 119 esophagogastroduodenoscopies, 6 flexible sigmoidoscopies, and 60 esophagogastroduodenoscopy/colonoscopies were performed. None of the patients in the study required endotracheal intubation, pharmacologic reversal, or experienced an adverse outcome as a result of changes in blood pressure, heart rate, or blood oxygen saturation. There were no significant differences in the rate of tachycardia (P = 0.749), bradycardia (P = 0.438), hypotension (systolic/diastolic, P = 0.460; mean arterial pressure, P = 0.571), or hypoxia (P = 0.787) between groups. The average length of time spent in each procedure and the average dose of sedation administered also did not differ significantly between the groups. Conclusions: Despite the presumed increased risk of cardiopulmonary complications, patients with OSA who undergo endoscopy with conscious sedation have clinically insignificant variations in cardiopulmonary parameters that do not differ from those without OSA. Costly preventative measures in patients with OSA are not warranted. Key Words: conscious sedation, obstructive sleep apnea, endoscopy, complications, safety
(J Clin Gastroenterol 2016;50:198–201)
Received for publication October 23, 2014; accepted January 28, 2015. From the *Department of Gastroenterology, The James A. Haley Veterans Affairs Hospital; and wDivision of Digestive Diseases and Nutrition, University of South Florida, Tampa, FL. The authors declare that they have nothing to disclose. Reprints: Christian M. Andrade, MD, Division of Digestive Diseases and Nutrition, University of South Florida Morsani College of Medicine, 12901 Bruce B. Downs Blvd, MDC 72, Tampa, FL 33612 (e-mail: [email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
E
ndoscopy is the preferred means for diagnosis and treatment of many acute and chronic gastrointestinal disorders. Adverse events are rare with an approximate 0.1% adverse event rate for upper gastrointestinal endoscopy and 0.2% adverse event rate for lower gastrointestinal interventions.1–4 During endoscopy, cardiopulmonary changes are commonly noted,5–7 and the majority of the complications are attributed to sedation.8,9 Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for complications, especially for cardiopulmonary complications. Recent studies suggest that this concern may be exaggerated,10–14 but conclusions have been limited by small sample size, retrospective analysis, and/or failure to include patients with documented OSA by polysomnography (Table 1). In the veteran population, where OSA is an increasingly common disorder, patients are at times denied endoscopy or endoscopy is performed at a higher level of care, thus incurring substantial health care costs. Given the lack of prospective randomized trials to support this practice, these preventative measures are controversial and unsubstantiated. The aim of the present study is to prospectively evaluate the safety of conscious sedation in veterans with documented OSA by polysomnography undergoing gastrointestinal endoscopy as compared with non-OSA patients.
PATIENTS AND METHODS After IRB approval, a total of 500 patients scheduled to undergo gastrointestinal endoscopy at the James A. Haley VA Hospital signed an informed consent. The enrollment period for this prospective cohort study was from July 27, 2011 to October 22, 2013. All patients at the James A. Haley VA scheduled to undergo an endoscopic procedure with OSA were eligible for enrollment. The exclusion criteria were age below 18 years, pregnancy, mild OSA, and patients scheduled with monitored anesthesia care (MAC). In total, 248 patients with confirmed moderate or severe OSA and 252 patients without OSA were enrolled. After enrollment and data collection, all emergency department (ED) and clinic visits documented in the James A. Haley VA Computerized Patient Record System (CPRS) up to 30 days postprocedure were reviewed for possible procedurerelated complications among patients with OSA. Only those patients with the diagnoses of moderate or severe OSA as measured by the gold standard, polysomnography, were enrolled. The diagnosis of moderate or
198 | www.jcge.com J Clin Gastroenterol Volume 50, Number 3, March 2016 Copyright r 2016 Wolters Kluwer Health, Inc. All rights reserved.
J Clin Gastroenterol
Volume 50, Number 3, March 2016
Safety of Conscious Sedation in Patients With OSA
TABLE 1. Comparative Studies Regarding the Safety of Endoscopy With Conscious Sedation in Patients With OSA
N
Design
OSA Definition
O2 Sat
HR
BP
Time
Mean Sedation Dose
Cha et al10 Mador et al11 Mador et al12
96 639 904
Prospective Retrospective Prospective
NS NS NS
NS NS NS
NS NS NS
— — NS
SD NS NS
Gill et al13 Khiani et al14 This study
400 233 487
Retrospective Prospective Prospective
PSG PSG Berlin & STOP-BANG Questionnaires PSG Berlin Questionnaire PSG
— NS NS
— — NS
— — NS
— — NS
+ NS NS
References
— indicates not evaluated; + , data reported as means; BP, blood pressure; HR, heart rate; NS, not significant; OSA, obstructive sleep apnea; PSG, polysomnography; SD, significant difference.
severe OSA was confirmed by the study staff after review of an overnight polysomnography result, which was performed utilizing standard protocol as per recommended guidelines by the American Academy of Sleep Medicine.15 Apnea was defined as an airflow reduction to
