UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.
UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.
Trials. 2020 Jul 8;21(1):627. doi: 10.1186/s13063-020-04536-3.
With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated.
Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3.
This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min.
ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.
院外心脏骤停（OHCA）的存活率为 6%至 11%，仍然是一个需要改善发病率和死亡率的医疗保健挑战。指南强调心肺复苏（CPR）和胸外按压（CC）的最高质量。尽量减少 CC 中断至关重要，因此增加 CC 分数（CCF）是提高生存率的一个独立因素。生存率与 CCF 目标的适宜性、CC 频率、CC 深度和短暂除颤前暂停显著正相关。CC 指导可提高对建议的依从性，并使 CC 目标更接近。通过延长两次 CC 接力之间的时间来提高 CCF 的可能性，以及实时反馈对 CC 质量的影响，必须进行研究。
在一项多中心随机试验中使用 2×2 析因设计，同时测试两个假设：（i）4 分钟接力节律与目前推荐的 2 分钟接力率相比，可提高 CCF（减少无血流时间），（ii）指导工具可提高 CC 的质量。主要结局（i）CCF 和（ii）正确的压缩评分将由实时反馈设备记录。2 年内将纳入 500 例成人非创伤性 OHCA。患者将按 1:1:1:1 随机分配，接受以下高级 CPR：2 分钟盲法、2 分钟指导、4 分钟盲法或 4 分钟指导。次要结局为 CC 的深度、频率和释放；长度（护理、无血流和低血流）；自主循环恢复率；高级 CPR 的特征；入院时的生存率；第 1 天和第 30 天（或重症监护病房出院）的存活和神经状态；神经元特异性烯醇化酶的剂量第 1 天和第 3 天。
这项研究将有助于评估实时反馈对 OHCA 复苏中 CC 质量的影响。它还将提供关于从目前推荐的 2 分钟延长到 4 分钟之间的接力节律的可行性的见解。
ClinicalTrials.gov，NCT03817892。于 2019 年 1 月 28 日注册。
