Randomized Clinical Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2015; 21(19): 5995-6000
Published online May 21, 2015. doi: 10.3748/wjg.v21.i19.5995
Efficacy and safety of a patient-positioning device (EZ-FIX) for endoscopic retrograde cholangiopancreatography
Seungho Lee, Joung-Ho Han, Hee Seung Lee, Ki Bae Kim, In-kwang Lee, Eun-Jong Cha, Young Duck Shin, Namgyu Park, Seon Mee Park
Seungho Lee, Joung-Ho Han, Hee Seung Lee, Ki Bae Kim, Namgyu Park, Seon Mee Park, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju 361-711, South Korea
In-kwang Lee, Eun-Jong Cha, Department of Biomedical Engineering, Chungbuk National University College of Medicine, Cheongju 361-711, South Korea
Young Duck Shin, Department of Anesthesiology, Chungbuk National University College of Medicine, Cheongju 361-711, South Korea
Author contributions: Lee S, Lee HS and Han JH conceptualized the study and acquired the data; Kim KB, Lee I, Cha EJ, Shin YD, Park N and Park SM assessed the results from the picture archiving and communication system images, and were involved in the final editing and writing of the manuscript.
Supported by Korea Healthcare Technology R and D Project, Ministry of Health and Welfare, South Korea (A100054).
Conflict-of-interest: All authors have no conflict of interest related to the manuscript.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Joung-Ho Han, MD, Department of Internal Medicine, College of Medicine, Chungbuk National University, 410 SungBong-Ro Heungdeok-Gu, Cheongju-Si ChungBuk 361-711, South Korea. joungho@cbnu.ac.kr
Telephone: +82-43-2696802 Fax: +82-43-2733252
Received: November 18, 2014
Peer-review started: November 18, 2014
First decision: December 26, 2014
Revised: January 15, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: May 21, 2015
Processing time: 183 Days and 7.9 Hours
Abstract

AIM: To assess the efficacy and safety of a patient-positioning device (EZ-FIX) for endoscopic retrograde cholangiopancreatography (ERCP).

METHODS: A total of 105 patients were randomized to the EZ-FIX (n = 53) or non-EZ-FIX (n = 52) group in this prospective study. Midazolam and propofol, titrated to provide an adequate level of sedation during therapeutic ERCP, were administered by trained registered nurses under endoscopist supervision. Primary outcome measures were the total dose of propofol and sedative-related complications, including hypoxia and hypotension. Secondary outcome measures were recovery time and sedation satisfaction of the endoscopist, nurses, and patients.

RESULTS: There was no significant difference in the rate of hypoxia, but there was a statistical trend (EX-FIX group; n = 4, 7.55%, control group; n = 6, 11.53%, P = 0.06). The mean total dose of propofol was lower in the EZ-FIX group than in the non-EZ-FIX group (89.43 ± 49.8 mg vs 112.4 ± 53.8 mg, P = 0.025). In addition, the EZ-FIX group had a shorter mean recovery time (11.23 ± 4.61 mg vs 14.96 ± 5.12 mg, P < 0.001). Sedation satisfaction of the endoscopist and nurses was higher in the EX-FIX group than in the non-EZ-FIX group. Technical success rates of the procedure were 96.23% and 96.15%, respectively (P = 0.856). Procedure-related complications did not differ by group (11.32% vs 13.46%, respectively, P = 0.735).

CONCLUSION: Using EZ-FIX reduced the total dose of propofol and the recovery time, and increased the satisfaction of the endoscopist and nurses.

Keywords: EZ-FIX; Patient-positioning device; Propofol; Sedation; Endoscopic retrograde cholangiopancreatography

Core tip: Although the incidence of sedation-related complications is low, it is closely associated with endoscopy-related morbidity and mortality. Many studies on the efficacy and safety of various sedative drugs have been conducted, but none used a patient-positioning device. We planned this study to improve the safety and efficacy of sedation during endoscopy by using a patient-positioning device (EZ-FIX).