远程实操培训与视频教学在可弯曲喉罩气道管理中的比较：一项多中心随机对照试验方案

文献信息

中文摘要

背景： 可弯曲喉罩气道（fLMA）管理是一项重要但技术要求高的气道技能，尤其对新手医生而言。当面对面模拟培训机会有限时，远程实操培训可能提供一种可扩展的替代方案，但证明此类培训能转化为患者临床操作表现的证据仍然很少。本试验旨在比较远程实操培训与标准化视频教学对新手医生学习fLMA管理的效果。
方法： 这是一项前瞻性、多中心、平行组、评估者盲法的优效性随机对照试验，在中国三家三级医院进行。三十名新手医生参与者将按1:1随机分配至远程实操培训组或视频教学组。两组均接受相同的标准化理论材料、操作演示视频和书面检查表。远程实操培训组额外接受使用气道任务训练器的远程监督刻意练习，并配有实时导师反馈。培训后，每位医生参与者将在经验丰富的麻醉医生直接监督下，对两名成年患者参与者进行fLMA管理。临床操作表现将被视频记录，并由两名盲法评估者使用可弯曲喉罩气道管理整体评定量表独立评估，该量表在前期研究中已建立效度证据。次要结局包括操作成功率、置入时间、通气参数、fLMA位置、操作相关并发症、学习进展和医生参与者满意度。
讨论： 本试验将评估结构化远程实操培训是否比标准化视频教学更能改善临床操作表现。通过结合随机教育干预、多中心临床评估、盲法视频评分和基于患者的结果评价，本研究旨在为远程模拟培训向临床气道管理的转化提供证据。
试验注册： 中国临床试验注册中心（ChiCTR）：ChiCTR2600121867。

英文摘要

BACKGROUND: Flexible laryngeal mask airway (fLMA) management is an important but technically demanding airway skill, particularly for novice physicians. Distance hands-on training may provide a scalable alternative when access to face-to-face simulation is limited, but evidence demonstrating transfer of such training to clinical performance in patients remains scarce. This trial aims to compare distance hands-on training with standardized video instruction for novice physicians learning fLMA management.
METHODS: This is a prospective, multicenter, parallel-group, rater-blinded, superiority randomized controlled trial conducted at three tertiary hospitals in China. Thirty novice physician participants will be randomized 1:1 to either distance hands-on training or video instruction. Both groups will receive identical standardized theoretical materials, a procedural demonstration video, and a written checklist. The distance hands-on training group will additionally receive remotely supervised deliberate practice using an airway task trainer with real-time instructor feedback. After training, each physician participant will perform fLMA management in two adult patient participants under direct supervision by experienced anesthesiologists. Clinical performance will be video-recorded and independently assessed by two blinded raters using the Flexible LMA Airway Management Global Rating Scale, for which validity evidence was established in a preceding study. Secondary outcomes include procedural success, insertion time, ventilation parameters, fLMA positioning, procedure-related complications, learning progression, and physician participant satisfaction.
DISCUSSION: This trial will evaluate whether structured distance hands-on training improves clinical procedural performance beyond standardized video instruction. By combining randomized educational intervention, multicenter clinical assessment, blinded video-based rating, and patient-based outcome evaluation, the study aims to provide evidence on the transfer of distance simulation training to clinical airway management.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR): ChiCTR2600121867.