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非气管插管与气管插管麻醉下胸腔镜手术术后肺部并发症及术中安全性的比较:一项随机、对照、双盲非劣效性试验。

Comparison of postoperative pulmonary complications and intraoperative safety in thoracoscopic surgery under non-intubated versus intubated anesthesia: a randomized, controlled, double-blind non-inferiority trial.

作者信息

Wang Lingfei, Wang Dan, Zhang Yanmei

机构信息

Department of Anesthesiology, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning, China.

出版信息

Updates Surg. 2024 Dec;76(8):2863-2873. doi: 10.1007/s13304-024-01935-y. Epub 2024 Aug 10.

DOI:10.1007/s13304-024-01935-y
PMID:39126533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11628443/
Abstract

PURPOSE

Traditional anesthesia for video-assisted thoracoscopy (VATS) such as double-lumen tracheal intubation (DLT) and one-lung ventilation (OLV), may lead to post-operative pulmonary complications (PPCs). Non-intubation VATS (NIVATS) is an anesthetic technique that avoided DLT and OLV, maybe avoiding the PPCs. So we hypothesized that NIVATS would non-inferiority to intubation VATS (IVATS) in the risk of developing PPCs and some safety indicators.

METHODS

This study is a randomised, controlled, double-blind, non-inferiority trial, 120 patients were randomly assigned to the NIVATS group and IVATS group according to 1:1. The primary outcome was the incidence of PPCs with a pre-defined non-inferiority margin of 10%. The second outcome was the safety indicators, including the incidence of cough/body movement, hypoxemia, malignant arrhythmia, regurgitation and aspiration, and transferring to endobronchial intubation intraoperatively (The malignant arrhythmia was defined as an arrhythmia that caused hemodynamic disturbances in a short period of time, resulting in persistent hypotension or even cardiac arrest in the patient).

RESULTS

There was no significant difference in demographic indicators such as gender and age between the two groups. The incidence of PPCs in the NIVATS group was non-inferior to that in the IVATS group (1.67% vs. 3.33%, absolute difference: - 1.67%; 95%CI - 7.25 to 3.91). In additionan, no significant differences were found between the two groups for the incidence of cough/body movement (10.00% vs. 11.67%, p = 0.77), the incidence of hypoxemia (25% vs. 18.33%, p = 0.38), the incidence of malignant arrhythmia (1.67% vs. 6.67%, p = 0.36), the incidence of regurgitation and aspiration (0% vs. 0%, p > 0.999) and the incidence of transferring to endobronchial intubation intraoperatively (0% vs. 0%, p > 0.999).

CONCLUSION

We conclude that when using the non-intubation anesthesia for VATS, the incidence of PPCs was not inferior to intubation anesthesia. Furthermore, NIVATS had little effect on perioperative safety.

摘要

目的

电视辅助胸腔镜手术(VATS)的传统麻醉方式,如双腔气管插管(DLT)和单肺通气(OLV),可能导致术后肺部并发症(PPCs)。非插管VATS(NIVATS)是一种避免使用DLT和OLV的麻醉技术,可能会避免PPCs。因此,我们假设在发生PPCs的风险和一些安全指标方面,NIVATS不劣于插管VATS(IVATS)。

方法

本研究是一项随机、对照、双盲、非劣效性试验,120例患者按1:1随机分为NIVATS组和IVATS组。主要结局是PPCs的发生率,预设非劣效界值为10%。次要结局是安全指标,包括咳嗽/身体移动、低氧血症、恶性心律失常、反流和误吸的发生率,以及术中转为支气管内插管的发生率(恶性心律失常定义为在短时间内引起血流动力学紊乱,导致患者持续低血压甚至心脏骤停的心律失常)。

结果

两组在性别、年龄等人口统计学指标上无显著差异。NIVATS组PPCs的发生率不劣于IVATS组(1.67%对3.33%,绝对差异:-1.67%;95%CI -7.25至3.91)。此外,两组在咳嗽/身体移动发生率(10.00%对11.67%,p = 0.77)、低氧血症发生率(25%对18.33%,p = 0.38)、恶性心律失常发生率(1.67%对6.67%,p = 0.36)、反流和误吸发生率(0%对0%,p > 0.999)以及术中转为支气管内插管的发生率(0%对0%,p > 0.999)方面均未发现显著差异。

结论

我们得出结论,在VATS中使用非插管麻醉时,PPCs的发生率不低于插管麻醉。此外,NIVATS对围手术期安全性影响很小。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/5f5d15089114/13304_2024_1935_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/24c50723e330/13304_2024_1935_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/fa5c47cf68ae/13304_2024_1935_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/762c3690b7ad/13304_2024_1935_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/5f5d15089114/13304_2024_1935_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/24c50723e330/13304_2024_1935_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/fa5c47cf68ae/13304_2024_1935_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/762c3690b7ad/13304_2024_1935_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d83d/11628443/5f5d15089114/13304_2024_1935_Fig4_HTML.jpg

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