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改良前路与传统后路超声引导下咽神经阻滞用于清醒经口气管插管的比较:一项随机非劣效性临床试验研究方案。

Comparison of modified anterior and traditional posterior accesses for ultrasound-guided superior laryngeal nerve block in awake endotracheal intubation: study protocol for a randomised non-inferiority clinical trial.

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.

The Research Units of West China (2018RU012)-Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, Chengdu, China.

出版信息

BMJ Open. 2023 Feb 28;13(2):e068779. doi: 10.1136/bmjopen-2022-068779.

Abstract

INTRODUCTION

Awake tracheal intubation (ATI) involves placing a tracheal tube in an awake, spontaneously breathing patient. Superior laryngeal nerve block (SLNB) can effectively abolish the glottic closure reflex, and blunt the sensation of the structures above the cords. A method that consists of SLNB along with translaryngeal injection (TLI) can provide satisfactory anaesthesia and intubating conditions. We present a novel modified access of SLNB, ultrasound (US)-guided anterior SLNB, to aid awake videolaryngoscopes-assisted endotracheal intubation in adult elective surgery patients, and we compare the effectiveness and safety to traditional US-guided posterior SLNB.

METHODS AND ANALYSIS

A total of 100 adult elective surgery patients requiring general endotracheal anaesthesia will be randomly assigned to the modified group (modified US-guided anterior SLNB) or the traditional group (traditional US-guided posterior SLNB). After SLNB, all participants will be performed with TLI. The primary outcome is the proportion of acceptable intubation conditions based on intubation scores. Secondary outcomes include: (a) the first-attempt intubation success rate, (b) haemodynamic changes during ATI, (c) time taken for airway anaesthesia and intubation, (d) recall of intubation, (e) participant perception of comfort during intubation, (f) perioperative complication rate. This report describes the study design of this randomised controlled trial.

ETHICS AND DISSEMINATION

The study protocol has been approved by an ethical committee of the West China Hospital (Sichuan University), and registered at the Chinese Clinical Trials Register (www.chictr.org.cn). Results will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2200058086.

摘要

简介

清醒气管插管(ATI)涉及在清醒、自主呼吸的患者中放置气管导管。喉上神经阻滞(SLNB)可有效消除声门关闭反射,并减轻声带上方结构的感觉。一种由 SLNB 联合经喉注射(TLI)组成的方法可以提供满意的麻醉和插管条件。我们提出了一种新的改良 SLNB 入路,即超声(US)引导下的前 SLNB,以辅助成人择期手术患者清醒视频喉镜辅助气管插管,并将其与传统的 US 引导下的后 SLNB 进行比较,评估其有效性和安全性。

方法和分析

共纳入 100 例需要全身麻醉下气管插管的择期手术成年患者,将其随机分为改良组(改良 US 引导下前 SLNB)或传统组(传统 US 引导下后 SLNB)。在 SLNB 后,所有患者均进行 TLI。主要结局是根据插管评分评估可接受的插管条件的比例。次要结局包括:(a)首次插管成功率,(b)ATI 期间的血流动力学变化,(c)气道麻醉和插管所需时间,(d)插管回忆,(e)患者对插管过程舒适度的感知,(f)围手术期并发症发生率。本报告描述了这项随机对照试验的研究设计。

伦理和传播

该研究方案已获得四川大学华西医院伦理委员会的批准,并在中国临床试验注册中心(www.chictr.org.cn)注册。研究结果将发表在同行评议的期刊上。

临床试验注册号

ChiCTR2200058086。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35be/9980353/beb0500ba185/bmjopen-2022-068779f01.jpg

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