Singer Ben, Reynolds Joshua C, Davies Gareth E, Wrigley Fenella, Whitbread Mark, Faulkner Mark, O'Brien Ben, Proudfoot Alastair G, Mathur Anthony, Evens Thomas, Field Jane, Monk Vivienne, Finney Simon J
St Bartholomew's Hospital, London, UK.
London's Air Ambulance, UK.
Resusc Plus. 2020 Dec;4:100029. doi: 10.1016/j.resplu.2020.100029. Epub 2020 Oct 8.
Out-of-hospital cardiac arrest carries a poor prognosis with survival less than 10% in many patient cohorts. Survival is inversely associated with duration of resuscitation as external chest compressions do not provide sufficient blood flow to prevent irreversible organ damage during a prolonged resuscitation. Extracorporeal membrane oxygenation (ECMO) instituted during cardiac arrest can provide normal physiological blood flows and is termed Extracorporeal Cardio-Pulmonary Resuscitation (ECPR). ECPR may improve survival when used with in-hospital cardiac arrests. This possible survival benefit has not been replicated in trials of out-of-hospital cardiac arrests, possibly because of the additional time it takes to transport the patient to hospital and initiate ECPR. Pre-hospital ECPR may shorten the time between cardiac arrest and physiological blood flows, potentially improving survival. It may also mitigate some of the neurological injury that many survivors suffer.
Sub30 is a prospective six patient feasibility study. The primary aim is to test whether it is possible to institute ECPR within 30 min of collapse in adult patients with refractory out of hospital cardiac arrest (OHCA). The secondary aims are to gather preliminary data on clinical outcomes, resource utilisation, and health economics associated with rapid ECPR delivery in order to plan any subsequent clinical investigation or clinical service. On study days a dedicated fast-response vehicle with ECPR capability will be tasked to out-of-hospital cardiac arrests in an area of London served by Barts Heart Centre. If patients suffer a cardiac arrest refractory to standard advanced resuscitation and meet eligibility criteria, ECPR will be started in the pre-hospital environment.
Delivering pre-hospital ECPR within 30 min of an out-of-hospital cardiac arrest presents significant ethical, clinical, governance and logistical challenges. Prior to conducting an efficacy study of ECPR the feasibility of timely and safe application must be demonstrated first. Extensive planning, multiple high-fidelity multiagency simulations and a unique collaboration between pre-hospital and in-hospital institutions will allow us to test the feasibility of this intervention in London. The study has been reviewed, refined and endorsed by the International ECMO Network (ECMONet).
Clinicaltrials. gov NCT03700125, prospectively registered October 9, 2018.
院外心脏骤停预后较差，在许多患者群体中生存率低于10%。生存率与复苏持续时间呈负相关，因为在长时间复苏过程中，胸外按压无法提供足够的血流以防止不可逆的器官损伤。心脏骤停期间实施体外膜肺氧合（ECMO）可提供正常的生理血流，这被称为体外心肺复苏（ECPR）。ECPR用于院内心脏骤停时可能会提高生存率。这种可能的生存益处尚未在院外心脏骤停试验中得到验证，可能是因为将患者转运至医院并启动ECPR需要额外的时间。院前ECPR可能会缩短心脏骤停与恢复生理血流之间的时间，从而有可能提高生存率。它还可能减轻许多幸存者所遭受的一些神经损伤。
Sub30是一项前瞻性的六例患者可行性研究。主要目的是测试对于难治性院外心脏骤停（OHCA）的成年患者，是否有可能在心脏骤停后30分钟内实施ECPR。次要目的是收集与快速实施ECPR相关的临床结局、资源利用和卫生经济学的初步数据，以便规划后续的临床研究或临床服务。在研究日，一辆具备ECPR能力的专用快速反应车辆将被派往由巴茨心脏中心服务的伦敦某区域处理院外心脏骤停事件。如果患者心脏骤停对标准高级复苏无效且符合入选标准，将在院前环境中启动ECPR。
在院外心脏骤停后30分钟内实施院前ECPR面临重大的伦理、临床、管理和后勤挑战。在进行ECPR疗效研究之前，必须首先证明及时安全应用的可行性。广泛的规划、多次高保真多机构模拟以及院前和院内机构之间独特的合作将使我们能够在伦敦测试这种干预措施的可行性。该研究已得到国际ECMO网络（ECMONet）的审查、完善和认可。
Clinicaltrials.gov NCT03700125，于2018年10月9日前瞻性注册。
