氩气心肺复苏（CPAr）：一项随机对照多中心临床试验方案

IF 2.4 Q3 CRITICAL CARE MEDICINE

Resuscitation plus Pub Date : 2025-09-10 DOI:10.1016/j.resplu.2025.101096

Giuseppe Ristagno , Lidia Staszewsky , Giulia Merigo , Aurora Magliocca , Alberto Cucino , Jennifer Meessen , Francesca Fumagalli , Matteo Pozzi , Alessandro Galazzi , Claudio Sandroni , Marco Meneguzzi , Anna Marangone , Chiara Robba , Erik Roman-Pognuz , Giovanni Salati , Edoardo Picetti , Deborah Novelli , Giacomo Bellani , Mauro Panigada , Lars Wik , Simone Savastano

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引用次数: 0

摘要

目的：氩气心肺复苏（CPAr）试验评估了院外心脏骤停（OHCA）复苏后昏迷成人使用70/30氩气/氧气（Ar/O2）混合气体进行复苏后通气与30% O2标准护理通气的临床神经保护效果和安全性。方法scpar是一项分配隐蔽、单盲、多中心、II期、上市前随机对照试验（RCT）。该研究旨在招募意大利三级重症监护病房（icu）的120名患者。符合条件的参与者是无意识的成年OHCA幸存者，呈现节奏震惊。在ICU入院时，患者按1:1的比例随机分组，通过实验呼吸机接受70/30 Ar/O2的4小时通气，或接受30% O2的标准ICU通气。所有患者均接受基于指南的复苏后护理。纳入是在延迟同意模式下进行的，一旦临床适宜，征得患者或法律代表的同意。主要临床疗效指标是48 h时的血清神经元特异性烯醇化酶（NSE）浓度，作为神经损伤的替代指标。次要结局包括心肌和多器官损伤的标志物，脑损伤的神经影像学迹象，生存和神经恢复（脑功能类别，CPC）长达6个 个月。安全性指标包括需要停药的氧去饱和的发生率、时间和持续时间，以及血流动力学不良事件。患者随访6 个月，在ICU/出院、ca后1个月和6个月进行结局评估。集中的血浆和血清生物库将支持未来的机制分析。结论cpar试验是第一项评估OHCA后人工呼吸有效性和安全性的随机对照试验，可能为未来复苏后护理的神经保护策略提供信息。registrationEudraCT-No审判。: 2018-003047-32;CTIS代码：2024-516864-27-00；ClinicalTrials.gov识别码：NCT05482945。

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CardioPulmonary resuscitation with Argon (CPAr): A protocol for a randomised controlled multicentre clinical trial

Aims

The CardioPulmonary resuscitation with Argon (CPAr) trial evaluates the clinical neuroprotective efficacy and safety of post-resuscitation ventilation with a 70/30 argon/oxygen (Ar/O₂) gas mixture compared to standard care ventilation with 30% O₂ in unconscious adults resuscitated from out-of-hospital cardiac arrest (OHCA).

Methods

CPAr is an allocation-concealed, single-blinded, multi-centre, phase II, pre-marketing, randomised controlled trial (RCT). The study aims to recruit 120 patients across tertiary intensive care units (ICUs) in Italy. Eligible participants are unconscious adult OHCA survivors with a shockable presenting rhythm. Upon ICU admission, patients are individually randomised in a 1:1 ratio to receive either 4-h ventilation with 70/30 Ar/O₂ via an experimental ventilator, or standard ICU ventilation with 30% O₂. All patients receive guideline-based post-resuscitation care. Inclusion is conducted under a deferred consent model, with consent obtained from patients or legal representatives once clinically appropriate.

The primary clinical efficacy outcome is serum neuron-specific enolase (NSE) concentration at 48 h, as a surrogate marker of neurological injury. Secondary outcomes include markers of myocardial and multiorgan injury, neuroimaging signs of brain injury, survival, and neurological recovery (Cerebral Performance Category, CPC) up to 6 months. Safety outcomes include the incidence, timing, and duration of O₂ desaturation requiring discontinuation of Ar, and haemodynamic adverse events. Patients are followed up to 6 months, with outcome assessment at ICU/hospital discharge, 1- and 6-months post-CA. A centralized plasma and serum biobank will support future mechanistic analyses.

Conclusion

CPAr trial is the first RCT to assess the efficacy and safety of Ar ventilation in humans following OHCA and may inform future neuroprotective strategies in post-resuscitation care.