Videolaryngoscopy versus direct laryngoscopy for tracheal intubation by anesthesia residents in the operating room: The randomized multicenter VILARE trial protocol

M. Taboada , M. Bermúdez , J. Fernández , A. Estany-Gestal , J.J. Amate , R. Ruido , M. Amor , R. Mato , C. Barreiro , P. Martínez , F. Ramasco , O. Vázquez , T. Seoane-Pillado
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引用次数: 0

Abstract

Introduction

Tracheal intubation using direct laryngoscopy with a Macintosh blade remains the standard technique in the operating room. However, this method requires precise anatomical alignment and direct visualization of the glottis, which can be challenging for anesthesia residents with limited experience. Multiple intubation attempts are associated with an increased risk of complications. Videolaryngoscopy allows indirect visualization of the glottis and enables real-time supervision and feedback during the procedure, potentially improving safety and facilitating learning. Although videolaryngoscopy has shown benefits in difficult airway scenarios and in experienced hands, evidence is limited on whether it improves first-pass success and reduces complications when used by anesthesia residents in patients without predicted airway difficulty. The aim of this study is to compare first-pass intubation success with videolaryngoscopy versus direct laryngoscopy when performed by anesthesia residents in the operating room.

Methods and analysis

The VILARE trial is a prospective, multicenter, randomized, open-label study. A total of 1008 adult patients undergoing elective or urgent surgery under general anesthesia, without predictors of difficult airway, will be randomized to undergo tracheal intubation using either a standard Macintosh direct laryngoscope or a Macintosh videolaryngoscope on the first attempt. All tracheal intubations will be performed by anesthesia residents. The primary endpoint is successful intubation on the first attempt. Secondary outcomes time for successful tracheal intubation, attempts for successful intubation, laryngoscopic vision with the modified Cormack-Lehane scale, need of adjuvant airway devices for intubation, subjective difficulty of intubation, and complications during tracheal intubation (e.g., desaturation, dental trauma).

Ethics and dissemination

The study protocol was approved November 28, 2024, by the Ethics Committee of Galicia, Spain (CEI-SL, code No. 2024/394).and was registered into the Clinicaltrials.gov clinical trials registry with No. NCT06842082. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If videolaryngoscopy improves first-attempt intubation success and reduces complications in anesthesia residents, its use may be recommended as the first-line device in anesthesia training programs.

Trial registration number

ClinicalTrials.gov Registry: NCT06842082.
手术室麻醉住院医师气管插管的视频喉镜与直接喉镜:随机多中心VILARE试验方案。
简介:使用Macintosh刀片的直接喉镜进行气管插管仍然是手术室的标准技术。然而,这种方法需要精确的解剖对准和声门的直接可视化,这对于经验有限的麻醉住院医师来说是具有挑战性的。多次插管尝试与并发症的风险增加有关。视频喉镜检查可以间接看到声门,并在手术过程中进行实时监督和反馈,潜在地提高安全性并促进学习。尽管视频喉镜检查在困难气道情况下和经验丰富的患者中显示出益处,但对于麻醉住院医师在没有预测气道困难的患者中使用它是否能提高首次通过成功率和减少并发症,证据有限。本研究的目的是比较麻醉住院医师在手术室中使用视频喉镜和直接喉镜进行首次插管的成功率。方法和分析:VILARE试验是一项前瞻性、多中心、随机、开放标签的研究。共有1008名在全麻下接受选择性或紧急手术的成人患者,没有气道困难的预测因素,将被随机分组,在第一次尝试时使用标准Macintosh直接喉镜或Macintosh视频喉镜进行气管插管。所有气管插管将由麻醉住院医师进行。主要终点是第一次插管成功。次要结果气管插管成功的时间、成功插管的尝试次数、改良Cormack-Lehane量表喉镜视力、辅助气管插管设备的需求、插管的主观难度以及气管插管期间的并发症(如去饱和、牙外伤)。伦理与传播:该研究方案于2024年11月28日由西班牙加利西亚伦理委员会(CEI-SL,代码No. 2024/394)批准。并在Clinicaltrials.gov临床试验注册中心注册,注册编号为。NCT06842082。知情同意是必需的。研究结果将在同行评议的期刊上发表,并在一个或多个科学会议上发表。如果视频喉镜检查提高了首次插管成功率并减少了麻醉住院医师的并发症,它可能被推荐作为麻醉培训计划的一线设备。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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