Department of Anesthesiology, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Beijing, People's Republic of China.
Medical Research Center, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Beijing, People's Republic of China.
BMJ Open. 2023 Jun 27;13(6):e071325. doi: 10.1136/bmjopen-2022-071325.
Endotracheal intubation (ETI) is a crucial but risky procedure, especially among patients suspected of difficult endotracheal intubation (DTI). Bronchoscope, as an improved technique commonly used in DTI, might encounter visualisation difficulties. The magnetic point-of-care ultrasound (MGPOCUS) provides a novel visualisation from the outside and enables estimation of the relative position and trajectory of the bronchoscope. The purpose of the study was to evaluate the efficiency of MGPOCUS-guided bronchoscopy, including the time required for successful ETI, the first attempt and overall success rate, the number of attempts, complications, and satisfaction with the visualization of the procedures.
The study is a randomised, parallel-group, single-blinded, single-centre study. Participants (n=108) will be recruited by the primary anaesthesiologist and randomised to groups of ETI with bronchoscope or MGPOCUS-guided bronchoscope. The primary outcome is the time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications, and satisfaction of visualisation. Cox regression with Bonferroni correction and linear mixed regression will be used to analyse the outcomes.
The trial protocol was approved by the ethics committees at the Peking Union Medical College Hospital (Institutional Review Board #ZS-3428). Findings will be disseminated through conference presentations and peer-reviewed journals.
NCT05647174.
气管插管(ETI)是一项至关重要但风险较大的操作,尤其是在疑似困难气管插管(DTI)的患者中。支气管镜作为一种常用于 DTI 的改良技术,可能会遇到可视化困难。即时床旁超声(MGPOCUS)提供了一种新颖的外部可视化方法,可以估计支气管镜的相对位置和轨迹。本研究的目的是评估 MGPOCUS 引导下支气管镜检查的效率,包括成功进行 ETI 所需的时间、首次尝试和总体成功率、尝试次数、并发症以及对程序可视化的满意度。
本研究是一项随机、平行组、单盲、单中心研究。参与者(n=108)将由主要麻醉师招募,并随机分为支气管镜引导 ETI 组和 MGPOCUS 引导支气管镜组。主要结局是首次尝试成功 ETI 所需的时间。次要结局包括操作时间、首次尝试和总体成功率、并发症和可视化满意度。将使用 Cox 回归和 Bonferroni 校正以及线性混合回归来分析结果。
试验方案已获得北京协和医学院医院伦理委员会的批准(机构审查委员会#ZS-3428)。研究结果将通过会议演讲和同行评议期刊进行传播。
NCT05647174。