1000 例患者快速序贯诱导时使用 McGrath MAC 可视喉镜与直接喉镜行气管插管的麻醉方案评估：随机多中心 LARA 试验研究方案。

Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol.

机构信息

Department of Anaesthesiology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany

Department of Anaesthesiology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.

出版信息

BMJ Open. 2021 Oct 6;11(10):e052977. doi: 10.1136/bmjopen-2021-052977.

DOI:10.1136/bmjopen-2021-052977

PMID:34615684

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8496391/

Abstract

INTRODUCTION

Rapid sequence induction of anaesthesia is indicated in patients with an increased risk of pulmonary aspiration. The main objective of the technique is to reduce the critical time period between loss of airway protective reflexes and rapid inflation of the cuff of the endotracheal tube to minimise the chance of aspiration of gastric contents. The COVID-19 pandemic has reinforced the importance of first-pass intubation success to ensure patient and healthcare worker safety. The aim of this study is to compare the first-pass intubation success rate (FPS) using the videolaryngoscopy compared with conventional direct laryngoscopy in surgical patients with a high risk of pulmonary aspiration.

METHODS AND ANALYSIS

The LARA trial is a multicentre, patient-blinded, randomised controlled trial. Consecutive patients requiring tracheal intubation are randomly allocated to either the McGrath MAC videolaryngoscope or direct laryngoscopy using the Macintosh laryngoscope. The expected rate of FPS is 92% in the McGrath group and 82% in the Macintosh group. Each group must include a total of 500 patients to achieve 90% power for detecting a difference at the 5% significance level. Successful intubation with the FPS is the primary endpoint. The secondary endpoints are the time to intubation, the number of intubation attempts, the necessity of airway management alternatives, the visualisation of the glottis using the Cormack and Lehane Score and the Percentage Of Glottic Opening Score and definite adverse events.

ETHICS AND DISSEMINATION

The project is approved by the local ethics committee of the Medical Association of the Rhineland Palatine state (registration number: 2020-15502) and medical ethics committee of the University of Freiburg (registration number: 21-1303). The results of this study will be made available in form of manuscripts for publication and presentations at national and international meetings.

TRIAL REGISTRATION

NCT04794764.

摘要

简介

在有发生误吸风险的患者中，需要进行快速序贯诱导麻醉。该技术的主要目的是减少从气道保护性反射丧失到快速充盈气管内导管套囊之间的关键时间间隔，以最大限度地降低胃内容物误吸的可能性。COVID-19 大流行强化了首次插管成功对确保患者和医护人员安全的重要性。本研究旨在比较视频喉镜与传统直接喉镜在有发生误吸风险的手术患者中首次插管成功率（FPS）。

方法和分析

LARA 试验是一项多中心、患者设盲、随机对照试验。连续需要气管插管的患者被随机分配到 McGrath MAC 视频喉镜或 Macintosh 喉镜进行直接喉镜检查。预计 McGrath 组的 FPS 率为 92%，Macintosh 组为 82%。每组必须包括总共 500 名患者，才能在 5%的显著性水平上检测到差异的 90%效力。以 FPS 成功插管为主要终点。次要终点包括插管时间、插管尝试次数、气道管理替代的必要性、使用 Cormack 和 Lehane 评分和 Glottic 开口评分百分比对声门的可视化以及明确的不良事件。