The Effectiveness of ECPR on the Scene and in Hospital for Out-of-hospital Cardi-ac Arrest (OHCA) in the Moravian-Silesian Region.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Hospital survival
研究概览
简要总结
On-scene extracorporeal pulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA) seems to speed up the start of extracorporeal membrane oxygenation (ECMO) and shorten low flow during cardiopulmonary resuscitation (CPR) in case of refractory cardiac arrest. The primary goal is to verify the benefit of on-scene ECPR in terms of shortening the collapse-to-ECMO interval. The secondary goal is to compare outcomes in the on-scene ECPR group with hospital cannulation.
详细描述
ECPR is a life-saving method for a selected group of patients who are refractory to standard resuscitation procedures. With the appropriate use of ECPR, it is possible to achieve a significant improvement in survival with good neurological outcomes even in patients who would otherwise die. The ECMO Centre Ostrava has been providing ECPR for OHCA since 2022 with cannulation in the hospital after prior transport from the scene under continuous resuscitation. A good neurological outcome is achieved in approximately 29% of patients, even though the collapse-ECMO interval is around 75 minutes. Shortening this interval, which is associated with improved outcomes, is possible by using a mobile team that per-forms cannulation directly on scene. Mobile ECPR will be carried out in cooperation with the Ostrava University Hospital and the Moravian-Silesian Region Emergency Medical Service. The primary objective is to verify the benefit of on-scene ECPR in terms of shortening the collapse-ECMO interval. The secondary objective is to compare the outcome in the on-scene ECPR group with hospital cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be used in the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumed cardiac aetiology of the cardiac arrest
- •Witnessed collapse
- •Bystander CPR
- •Estimated age ≤ 70 years
- •Body weight ≥15 Kg
排除标准
- •Known terminal malignant disease
- •Known terminal chronic disease
研究组 & 干预措施
ECPR on scene
On-scene ECPR cannulation by mobile ECMO team according to protocol if the location of the arrest and circumstances appear to be suitable (distance from the ECMO centre, transport logistics, in an ambulance/at home, etc.)
干预措施: Prehospital ECMO cannulation on scene of cardiac arrest (Procedure)
ECPR in hospital
Hospital ECPR cannulation at Emergency Department by ECMO team accord-ing to protocol if a on scene ECPR call-out was not indicated.
干预措施: Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation (Procedure)
结局指标
主要结局
Hospital survival
时间窗: 30 days after the cardiac arrest
Hospital survival will be assessed 30 days after the cardiac arrest
ICU stay
时间窗: Through the ICU stay, on average 12 days
The length of the Intensive Care Unit (ICU) stay will be assessed in days.
Neurologic outcomes
时间窗: 30 days after the cardiac arrest
Neurologic outcomes will be assessed in patients using the Cerebral Performance Category (CPC) score. The CPC score is a 1-to-5 scale assessing neurological outcome, most commonly after cardiac arrest, where 1 is best (normal brain function) and 5 is worst (brain death).
次要结局
- Collapse to ECMO interval(One hour)
- Collapse to ECMO interval(From the collapse (cardiac arrest) to ECMO initiation)
- Long-term outcome - Survival(6 months after the collapse)
- Long-term outcome - Quality of Life(6 months after the collapse)