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模拟小儿院外心脏骤停时中级气道管理对通气参数的影响:一项多中心随机交叉试验

Effect of intermediate airway management on ventilation parameters in simulated paediatric out-of-hospital cardiac arrest: a multicentre randomised crossover trial.

作者信息

Stuby Loric, Bourgeois Laurent, Tinembart Jean-Marie, Mühlemann Elisa, Thurre David, Siebert Johan N, Suppan Laurent

机构信息

Genève TEAM Ambulances, Emergency Medical Services, Geneva, Switzerland.

ESAMB - College of Higher Education in Ambulance Care, Conches, Switzerland.

出版信息

Swiss Med Wkly. 2025 May 16;155:4079. doi: 10.57187/s.4079.

DOI:10.57187/s.4079
PMID:40450752
Abstract

INTRODUCTION

Paediatric out-of-hospital cardiac arrest survival rates remain low despite advancements in resuscitation science. Prompt restoration of oxygenation is crucial for achieving return of spontaneous circulation. Delays in airway management are associated with decreased survival rates. The primary objective of this study was to determine whether early i-gel® insertion, without prior bag-valve-mask, could enhance ventilation parameters in comparison with a bag-valve-mask-only approach.

METHODS

This multicentre, randomised crossover study used a simulated paediatric out-of-hospital cardiac arrest model to compare standard American Heart Association guidelines with an intermediate airway management approach using an i-gel® device. Paramedics and emergency medical technicians from eight participating emergency medical service centres were randomised into teams and performed two 10-minute simulations. Each team employed one of the airway management strategies. Data was automatically collected by a high-fidelity manikin. The primary outcome was alveolar ventilation per minute. Secondary outcomes included metrics for ventilation quality and timing, chest compression performance and timing of adrenaline administration. Statistical analysis involved paired tests suitable for the crossover design.

RESULTS

From 30 January 2023 to 13 June 2023, 68 participants formed 34 resuscitation teams. Minute alveolar ventilation was similar between intermediate airway management and bag-valve-mask strategies (difference: 36 ml [95% CI -28 to 99]). A sensitivity analysis showed comparable results. Intermediate airway management delivered more ventilations, but bag-valve-mask enabled quicker ventilation initiation and more ventilations within the target volume. Chest compression fraction was higher with intermediate airway management, although chest recoil was better with bag-valve-mask. Adrenaline administration rates and times were similar in both strategies. Minor protocol deviations were observed but did not introduce significant bias. The study was underpowered due to an error in the sample size calculation, limiting the robustness and generalisability of the findings.

CONCLUSION

In a simulated paediatric out-of-hospital cardiac arrest model, immediate use of intermediate airway management did not show relevant differences compared to bag-valve-mask. Intermediate airway management devices cannot be recommended as first-line choice but may be considered when bag-valve-mask is challenging. Whichever device is used, the focus should remain on providing high-quality ventilations.

CLINICALTRIALS

gov ID: NCT05498402.

摘要

引言

尽管复苏科学取得了进展,但儿科院外心脏骤停的存活率仍然很低。迅速恢复氧合对于实现自主循环恢复至关重要。气道管理延迟与存活率降低有关。本研究的主要目的是确定在不预先使用袋阀面罩的情况下早期插入i-gel®是否能比仅使用袋阀面罩的方法提高通气参数。

方法

这项多中心、随机交叉研究使用模拟儿科院外心脏骤停模型,将美国心脏协会标准指南与使用i-gel®设备的中级气道管理方法进行比较。来自八个参与急救医疗服务中心的护理人员和急救医疗技术人员被随机分成小组,并进行两次10分钟的模拟。每个小组采用一种气道管理策略。数据由高保真人体模型自动收集。主要结果是每分钟肺泡通气量。次要结果包括通气质量和时间、胸外按压表现以及肾上腺素给药时间的指标。统计分析采用适合交叉设计的配对检验。

结果

从2023年1月30日至2023年6月13日,68名参与者组成了34个复苏小组。中级气道管理和袋阀面罩策略之间的每分钟肺泡通气量相似(差异:36毫升[95%置信区间-28至99])。敏感性分析显示了类似的结果。中级气道管理进行的通气次数更多,但袋阀面罩能更快开始通气且在目标容积内通气次数更多。中级气道管理的胸外按压分数更高,尽管袋阀面罩的胸廓回弹更好。两种策略的肾上腺素给药率和时间相似。观察到有轻微的方案偏差,但未引入显著偏倚。由于样本量计算错误,该研究的效能不足,限制了研究结果的稳健性和普遍性。

结论

在模拟儿科院外心脏骤停模型中,与袋阀面罩相比,立即使用中级气道管理未显示出相关差异。中级气道管理设备不能被推荐作为一线选择,但在袋阀面罩使用有困难时可予以考虑。无论使用哪种设备,重点都应放在提供高质量通气上。

临床试验

美国国立医学图书馆临床试验注册中心标识符:NCT05498402

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