Department of Intensive Care, Hopital Erasme, Université Libre de Bruxelles (ULB), Route de Lennik, 808, Bruxelles 1070, Belgium.
BMC Emerg Med. 2013 Nov 25;13:21. doi: 10.1186/1471-227X-13-21.
Therapeutic hypothermia (TH, 32-34°C) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest (OHCA) with ventricular tachycardia or fibrillation. Earlier initiation of TH may increase the beneficial effects. Experimental studies have suggested that starting TH during cardiopulmonary resuscitation (CPR) may further enhance its neuroprotective effects. The aim of this study was to evaluate whether intra-arrest TH (IATH), initiated in the field with trans nasal evaporative cooling (TNEC), would provide outcome benefits when compared to standard of care in patients being resuscitated from OHCA.
METHODS/DESIGN: We describe the methodology of a multi-centre, randomized, controlled trial comparing IATH delivered through TNEC device (Rhinochill, Benechill Inc., San Diego, CA, USA) during CPR to standard treatment, including TH initiated after hospital admission. The primary outcome is neurological intact survival defined as cerebral performance category 1-2 at 90 days among those patients who are admitted to the hospital. Secondary outcomes include survival at 90 days, proportion of patients achieving a return to spontaneous circulation (ROSC), the proportion of patients admitted alive to the hospital and the proportion of patients achieving target temperature (<34°C) within the first 4 hours since CA.
This ongoing trial will assess the impact of IATH with TNEC, which may be able to rapidly induce brain cooling and have fewer side effects than other methods, such as cold fluid infusion. If this intervention is found to improve neurological outcome, its early use in the pre-hospital setting will be considered as an early neuro-protective strategy in OHCA.
NCT01400373.
研究表明，对于伴有室性心动过速或心室颤动的院外心脏骤停（OHCA）昏迷幸存者，治疗性低体温（32-34°C）可改善神经预后。更早地开始低体温治疗可能会增加有益效果。实验研究表明，在心肺复苏（CPR）期间开始低体温治疗可能会进一步增强其神经保护作用。本研究旨在评估在 OHCA 复苏患者中，与标准治疗相比，在现场通过经鼻蒸发冷却（TNEC）启动的心脏骤停期间低体温（IATH）是否会提供获益。
方法/设计：我们描述了一项多中心、随机、对照试验的方法，该试验比较了在 CPR 期间通过 TNEC 设备（Rhinochill，Benechill Inc.，圣地亚哥，CA，美国）给予 IATH 与标准治疗（包括入院后开始的低体温治疗）的效果。主要结局是 90 天时神经功能完整存活，定义为入院患者的脑功能表现分类 1-2 级。次要结局包括 90 天时的存活率、恢复自主循环（ROSC）的患者比例、存活入院的患者比例以及在 CA 后 4 小时内达到目标温度（<34°C）的患者比例。
正在进行的这项试验将评估 TNEC 诱导的 IATH 的影响，这种方法可能能够快速诱导脑冷却，并且比其他方法（如冷液输注）的副作用更少。如果这种干预措施被发现可以改善神经预后，那么将考虑在院前环境中尽早使用这种方法作为 OHCA 的早期神经保护策略。
NCT01400373。
