一项全国多中心的院前 ECPR 递进式研究；ON-SCENE 研究的设计和原理。
A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study.
机构信息
Department of Intensive Care, Erasmus University Medical Centre, Dr. Molewaterplein 40, Rotterdam, 3015 GD, the Netherlands.
Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, 3015 GD, the Netherlands.
出版信息
Scand J Trauma Resusc Emerg Med. 2024 Apr 17;32(1):31. doi: 10.1186/s13049-024-01198-x.
BACKGROUND
The likelihood of return of spontaneous circulation with conventional advanced life support is known to have an exponential decline and therefore neurological outcome after 20 min in patients with a cardiac arrest is poor. Initiation of venoarterial ExtraCorporeal Membrane Oxygenation (ECMO) during resuscitation might improve outcomes if used in time and in a selected patient category. However, previous studies have failed to significantly reduce the time from cardiac arrest to ECMO flow to less than 60 min. We hypothesize that the initiation of Extracorporeal Cardiopulmonary Resuscitation (ECPR) by a Helicopter Emergency Medical Services System (HEMS) will reduce the low flow time and improve outcomes in refractory Out of Hospital Cardiac Arrest (OHCA) patients.
METHODS
The ON-SCENE study will use a non-randomised stepped wedge design to implement ECPR in patients with witnessed OHCA between the ages of 18-50 years old, with an initial presentation of shockable rhythm or pulseless electrical activity with a high suspicion of pulmonary embolism, lasting more than 20, but less than 45 min. Patients will be treated by the ambulance crew and HEMS with prehospital ECPR capabilities and will be compared with treatment by ambulance crew and HEMS without prehospital ECPR capabilities. The primary outcome measure will be survival at hospital discharge. The secondary outcome measure will be good neurological outcome defined as a cerebral performance categories scale score of 1 or 2 at 6 and 12 months.
DISCUSSION
The ON-SCENE study focuses on initiating ECPR at the scene of OHCA using HEMS. The current in-hospital ECPR for OHCA obstacles encompassing low survival rates in refractory arrests, extended low-flow durations during transportation, and the critical time sensitivity of initiating ECPR, which could potentially be addressed through the implementation of the HEMS system. When successful, implementing on-scene ECPR could significantly enhance survival rates and minimize neurological impairment.
TRIAL REGISTRATION
Clinicaltyrials.gov under NCT04620070, registration date 3 November 2020.
背景
众所周知，常规高级生命支持下自主循环恢复的可能性呈指数下降，因此心脏骤停后 20 分钟患者的神经预后较差。如果及时在选定的患者类别中使用，在复苏期间启动静脉动脉体外膜肺氧合（ECMO）可能会改善结果。然而，先前的研究未能将从心脏骤停到 ECMO 流量的时间显著减少到 60 分钟以下。我们假设直升机紧急医疗服务系统（HEMS）启动体外心肺复苏（ECPR）将减少低流量时间并改善难治性院外心脏骤停（OHCA）患者的结局。
方法
ON-SCENE 研究将使用非随机分步楔形设计在 18-50 岁有目击 OHCA 病史的患者中实施 ECPR，初始表现为可除颤节律或无脉性电活动，高度怀疑肺栓塞，持续时间超过 20 分钟但少于 45 分钟。患者将由救护车工作人员和具有院前 ECPR 能力的 HEMS 进行治疗，并与没有院前 ECPR 能力的救护车工作人员和 HEMS 进行治疗进行比较。主要结局指标是出院时的生存率。次要结局指标是良好的神经功能预后，定义为 6 个月和 12 个月时的脑功能分类量表评分 1 或 2。
讨论
ON-SCENE 研究侧重于使用 HEMS 在 OHCA 现场启动 ECPR。目前 OHCA 的院内 ECPR 存在障碍，包括难治性骤停存活率低、转运期间低流量持续时间延长以及启动 ECPR 的时间敏感性至关重要，通过实施 HEMS 系统可能会解决这些问题。如果成功实施现场 ECPR，可以显著提高生存率并最大限度地减少神经损伤。
试验注册
Clinicaltrials.gov 下的 NCT04620070，注册日期 2020 年 11 月 3 日。
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