Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 16, 2021; 9(20): 5479-5489
Published online Jul 16, 2021. doi: 10.12998/wjcc.v9.i20.5479
Prospective, randomized comparison of two supplemental oxygen methods during gastroscopy with propofol mono-sedation in obese patients
Liu-Jia-Zi Shao, Fang-Xiao Hong, Fu-Kun Liu, Lei Wan, Fu-Shan Xue
Liu-Jia-Zi Shao, Fang-Xiao Hong, Fu-Kun Liu, Lei Wan, Fu-Shan Xue, Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
Author contributions: Shao LJZ and Hong FX contributed equally to this study; Shao LJZ, Hong FX and Xue FS contributed to the study design, planning, and implementation, and wrote the manuscript; Shao LJZ and Hong FX analyzed the data; Wan L and Liu FK contributed to study implementation, data analysis, and revision of the manuscript.
Supported by “Renfu” Research Fund by Chinese Society of Digestive Endoscopy, No. CSDE022020090001.
Institutional review board statement: This study was approved by the Ethics Committee of Beijing Friendship Hospital, China (Ethics Committee number: 2017-P2-009-02).
Clinical trial registration statement: The trial protocol has been registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-17013089).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: None of the authors has any financial or other potential conflicts of interest related to this work.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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/
Corresponding author: Fu-Shan Xue, MD, Professor, Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong’an Road, Xicheng District, Beijing 100050, China. fushanxue@outlook.com
Received: March 16, 2021
Peer-review started: March 16, 2021
First decision: May 1, 2021
Revised: May 7, 2021
Accepted: May 19, 2021
Article in press: May 19, 2021
Published online: July 16, 2021
Processing time: 113 Days and 3.3 Hours
ARTICLE HIGHLIGHTS
Research background

Hypoxemia by respiratory depression and airway obstruction during upper gastrointestinal endoscopy with sedation is a common concern, especially in obese patients. The nasal cannula is one of the most convenient tools for supplemental oxygen, but it cannot overcome upper airway obstruction. Compared with a nasal cannula (prongs), a conventional nasopharyngeal airway can provide improved efficiency of supplemental oxygen during upper gastrointestinal endoscopy with sedation, but the insertion of the nasopharyngeal airway is an invasive procedure with a potential risk of airway injury.

Research motivation

In view of the significant limitations of available supplemental oxygen methods, it is necessary to find new effective measures for administering supplemental oxygen during upper gastrointestinal endoscopy with sedation. The Wei nasal jet tube (WNJT) is a new special nasopharyngeal airway made of soft material. Our previous work in patients with normal body mass index (BMI) demonstrated that the WNJT compared with a nasal cannula for supplemental oxygen at 5 L/min is more effective for the prevention of hypoxemia during gastroscopy with propofol mono-sedation. For obese patients with an increased risk of hypoxemia during gastroscopy with sedation, however, it remains unclear whether the WNJT is an effective and safe tool for supplemental oxygen.

Research objectives

In this study, we aimed to determine whether the WNJT performs better than a nasal cannula (prongs) for the prevention of hypoxemia during gastroscopy with propofol mono-sedation in obese patients when moderate oxygen flow is provided.

Research methods

To address the question of whether the WNJT performs better than nasal cannula (prongs) for the prevention of hypoxemia during gastroscopy with propofol mono-sedation when moderate oxygen flow is provided in obese patients, we designed this study as a prospective, randomized controlled trial in which patients with a BMI of 30 kg/m2 or greater, undergoing elective gastroscopy with propofol mono-sedation, were randomized into the two groups to receive either the WNJT or a nasal cannula for supplemental oxygen at a 5 L/min flow rate. The primary endpoint was the incidence of hypoxemia and of severe hypoxemia during gastroscopy.

Research results

A total of 103 obese patients were randomized into the two groups, but 49 patients in the WNJT group and 52 patients in the nasal cannula group were used for data analysis, because two patients in the WNJT group were excluded. The total incidence of hypoxemia and of severe hypoxemia during gastroscopy was significantly decreased in the WNJT group compared with the nasal cannula group. Epistaxis by device insertion in the WNJT group occurred in three patients. Other than epistaxis, the occurrence of adverse events was similar between the devices. The two devices did not produce a statistically significant difference in patient satisfaction, but the WNJT did provide increased satisfaction among anesthetists and physicians.

Research conclusions

During gastroscopy with propofol mono-sedation in obese patients, the WNJT, compared with a nasal cannula for supplemental oxygen, can significantly reduce the occurrence of hypoxemia and improve satisfaction among anesthetists and physicians, although its use may lead to epistaxis in a few patients.

Research perspectives

With a moderate oxygen flow of 5 L/min, the WNJT performs better than a nasal cannula (prongs) for the prevention of hypoxemia during gastroscopy with propofol mono-sedation in obese patients. Thus, in view of a clinically acceptable risk-benefit ratio, the WNJT should be recommended as an alternative tool for supplemental oxygen for the prevention of hypoxemia during gastroscopy with propofol mono-sedation in obese patients.