A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study

Samir Ali, Xavier Moors, Hans van Schuppen, Lars Mommers, Ellen Weelink, Christiaan L. Meuwese, Merijn Kant, Judith van den Brule, Carlos Elzo Kraemer, Alexander P. J. Vlaar, Sakir Akin, Annemiek Oude Lansink-Hartgring, Erik Scholten, Luuk Otterspoor, Jesse de Metz, Thijs Delnoij, Esther M. M. van Lieshout, Robert-Jan Houmes, Dennis den Hartog, Diederik Gommers, Dinis Dos Reis Miranda
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引用次数: 0

Abstract

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. 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. 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. Clinicaltyrials.gov under NCT04620070, registration date 3 November 2020.
全国多中心院前 ECPR 阶梯式楔形研究;ON-SCENE 研究的设计与原理
众所周知,使用传统的高级生命支持系统恢复自主循环的可能性呈指数下降,因此心脏骤停患者在 20 分钟后的神经功能预后很差。在复苏过程中启动静脉体外膜肺氧合(ECMO),如果能及时用于选定的患者类别,可能会改善预后。然而,之前的研究未能将从心脏骤停到 ECMO 流入的时间显著缩短至 60 分钟以内。我们假设,由直升机紧急医疗服务系统(HEMS)启动体外心肺复苏(ECPR)将缩短低流量时间,并改善难治性院外心脏骤停(OHCA)患者的预后。ON-SCENE研究将采用非随机阶梯式楔形设计,对年龄在18-50岁之间、初始表现为可电击心律或无脉电活动、高度怀疑肺栓塞、持续时间超过20分钟但少于45分钟的目击OHCA患者实施ECPR。患者将由具备院前 ECPR 功能的救护人员和急救车进行治疗,并与不具备院前 ECPR 功能的救护人员和急救车的治疗进行比较。主要结果指标是出院时的存活率。次要结果指标是良好的神经功能结果,即 6 个月和 12 个月时脑功能分类量表评分为 1 分或 2 分。ON-SCENE 研究的重点是在 OHCA 现场使用 HEMS 启动 ECPR。目前针对 OHCA 的院内 ECPR 存在障碍,包括难治性骤停的存活率低、转运期间低流量持续时间长以及启动 ECPR 的关键时间敏感性,这些都有可能通过实施 HEMS 系统来解决。一旦成功,现场 ECPR 的实施将大大提高存活率并最大程度地减少神经损伤。Clinicaltyrials.gov 下的 NCT04620070,注册日期为 2020 年 11 月 3 日。
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