气管插管型喉罩与直接喉镜：一项交叉随机对照新生儿人体模型试验

Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial.

作者信息

Monfredini Chiara, Cavallin Francesco, Ouedraogo Paul, Ezzahraoui Leila, Pasta Elisa, Trevisanuto Daniele, Villani Paolo Ernesto

机构信息

Department of Woman and Child Health, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy.

Department of Woman and Maternal-infantile Health, Fondazione Poliambulanza Istituto Ospedaliero, Via Bissolati, 57, Brescia, 25124, Italy.

出版信息

Ital J Pediatr. 2025 Jun 20;51(1):196. doi: 10.1186/s13052-025-01988-8.

DOI:10.1186/s13052-025-01988-8

PMID:40542416

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12181870/

Abstract

BACKGROUND

We aimed to compare endotracheal intubation through a laryngeal mask vs. using a direct laryngoscope in a manikin simulating a term infant.

METHODS

A randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. a direct laryngoscope in a manikin simulating a term infant. Thirty-four tertiary neonatal intensive care unit consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy participated. The primary outcome measure was the success of the procedure at the first attempt. The secondary outcome measures included the total time of endotracheal tube positioning and participant's opinion on insertion difficulty and overall difficulty.

RESULTS

Success at first attempt was 34/34 with the laryngeal mask (100%) and 26/34 with the direct laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5-41%; p = 0.008). Median time of endotracheal tube positioning was 24 s (IQR 19-30) with both devices (p = 0.86). Insertion difficulty (p = 0.96) and overall difficulty (p = 0.99) were not statistically different between the devices.

CONCLUSIONS

In a term infant manikin model, positioning the endotracheal tube through the laryngeal mask increased the success at the first attempt compared to direct laryngoscopy, without extending the duration of the procedure or affecting the perceived difficulty.

REGISTRATION

clinicaltrial.gov NCT06263790. Registered 16 February 2024, https://clinicaltrials.gov/study/NCT06263790 .

摘要

背景

我们旨在比较在模拟足月儿的人体模型中，通过喉罩进行气管插管与使用直接喉镜进行气管插管的效果。

方法

在模拟足月儿的人体模型中，对通过喉罩与直接喉镜进行气管插管开展一项随机、对照、交叉（AB/BA）试验。34名曾有过喉罩气道插管和直接喉镜检查经验的三级新生儿重症监护病房顾问医生和儿科住院医师参与了研究。主要结局指标是首次尝试操作的成功率。次要结局指标包括气管导管定位的总时间以及参与者对插入难度和总体难度的看法。

结果

使用喉罩首次尝试的成功率为34/34（100%），使用直接喉镜首次尝试的成功率为26/34（76%）（百分比差异为24%，95%置信区间为5 - 41%；p = 0.008）。两种器械气管导管定位的中位时间均为24秒（四分位间距为19 - 30秒）（p = 0.86）。两种器械在插入难度（p = 0.96）和总体难度（p = 0.99）方面无统计学差异。