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喉管evo在心脏骤停期间通气中球囊面罩通气与容量控制通气的比较——一项在人体遗体供者中开展的前瞻性随机研究

Comparison of bag-valve-device ventilation and volume-controlled ventilation with laryngeal tube evo in intra-arrest ventilation-a prospective randomized study in human body donors.

临床研究咽喉科IF 4Q1

文献信息

中文摘要

背景: 本研究评估了新型声门上气道装置喉管evo在机械胸外按压期间心脏骤停通气治疗中对目标通气参数的影响,比较球囊面罩通气与容量控制通气。
方法: 将经Thiel法防腐处理的人体遗体供者纳入标准化复苏场景。在机械心肺复苏期间,采用随机顺序使用喉管evo进行球囊面罩通气和容量控制通气。记录呼气潮气量(Vte)及每公斤体重呼气潮气量(Vte/kgBW)、潮气量差值(理想潮气量与呼气潮气量之差;ΔVt)、漏气量(Vleak)、峰值压(Ppeak)、平均压(Pmean)和平台压(Pplat)以及呼吸频率。主要疗效终点为Vte。
结果: 共纳入5具遗体供者。尽管1具供者(20%)在所有通气模式下均成功通气,但3具仅能在其中一种模式下通气(球囊面罩通气=20%;容量控制通气=40%)。1具供者(20%)在任何模式下均无法充分通气。球囊面罩通气的平均Vte为91.73±66.3 ml,而容量控制通气为142.93±115.05 ml。两种通气模式的比较显示,容量控制通气的Vte更高(50.27 ml;95%置信区间(CI):7.56至92.97;p=0.02)、Vte/kgBW更高(0.8 ml;95% CI:0.05至1.56;p=0.04)、Pmean更高(5.23 mbar;95% CI:4至6.47;p<0.0001)和Pplat更高(10.36 mbar;95% CI:8.08至12.64;p<0.0001),但ΔVt更低(-50.3 ml;95% CI:-93至-7.59;p=0.02)且呼吸频率更低(-10.83/分;95% CI:-17.29至-4.36;p=0.001)。
结论: 在使用喉管evo进行机械心肺复苏期间的非同步通气中,与球囊面罩通气相比,容量控制通气导致更高的Vte和Vte/kgBW,但ΔVt和呼吸频率更低。未来研究应评估喉管evo在机械心肺复苏期间院前使用的情况。当对其有效性存在疑虑时,应进行同步通气(30:2)。
试验注册: 德国临床试验注册中心;唯一标识符:DRKS00037836。注册日期:2025年9月9日[1]。

英文摘要

BACKGROUND: This study evaluated the effects of the new supraglottic airway device known as laryngeal tube evo on target parameters of ventilation therapy during mechanical chest compressions in intra-arrest ventilation with bag-valve-device ventilation vs. volume-controlled ventilation.
METHODS: Thiel-embalmed human body donors were included in a standardized resuscitation scenario. Ventilation was performed in a randomized order using the laryngeal tube evo for bag-valve-device ventilation and volume-controlled ventilation during mechanical cardiopulmonary resuscitation. Expiratory (Vte) and expiratory tidal volumes per kg body weight (Vte/kgBW); delta tidal volume (difference between ideal and expiratory tidal volume; ΔVt); leakage volume (Vleak); peak (Ppeak); mean (Pmean) and plateau (Pplat) pressures and respiratory rates were recorded. The primary efficacy endpoint was Vte.
RESULTS: Five body donors were included. Although one donor (20%) was successfully ventilated with all ventilation modes, three could only be ventilated with one of the modes (bag-valve-device ventilation = 20%; volume-controlled ventilation = 40%). One donor (20%) could not be sufficiently ventilated with any of the modes. Mean Vte was 91.73 ± 66.3 ml with bag-valve-device ventilation versus 142.93 ± 115.05 ml with volume-controlled ventilation. The comparison of both ventilation modes revealed higher Vte (50.27 ml; 95% confidence interval (CI): 7.56 to 92.97; p = 0.02), Vte/kgBW (0.8 ml; 95% CI: 0.05 to 1.56; p = 0.04), Pmean (5.23 mbar; 95% CI: 4 to 6.47; p < 0.0001) and Pplat (10.36 mbar; 95% CI: 8.08 to 12.64; p < 0.0001), but lower ∆Vt (- 50.3 ml; 95% CI: - 93 to - 7.59; p = 0.02) and respiratory rates (- 10.83/min; 95% CI: - 17.29 to - 4.36; p = 0.001) for volume-controlled ventilation.
CONCLUSIONS: Comparing volume-controlled ventilation with bag-valve-device ventilation for asynchronous ventilation during mechanical cardiopulmonary resuscitation using the laryngeal tube evo, volume-controlled ventilation resulted in higher Vte and Vte/kgBW, but lower ∆Vt and respiratory rates. Future studies should evaluate laryngeal tube evo in prehospital use during mechanical cardiopulmonary resuscitation. When doubts regarding its effectiveness are present, synchronous ventilation (30:2) should be performed.
TRIAL REGISTRATION: German Clinical Trials Register; unique identifier: DRKS00037836. Registered on September 09, 2025 [1].