Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time from cardiac arrest (collapse) to implantation of ECMO
研究概览
简要总结
Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.
详细描述
Patients undergoing cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) have a poor prognosis and a good long-term neurological outcome is achieved in about 10% of them. Extracorporeal membrane oxygenation (ECMO) can lead to an improvement in neurological outcome of up to 30% in a selected group of these critically ill patients. CPR for OHCA using ECMO in the hospital after patient admission (ECPR) is very demanding and depends on the best collaboration of pre-hospital care components with the hospital management. As good as the coordination of the different phases of care and transport is, patients often arrive to the hospital relatively late (over 60 minutes), and although the process of diagnosis and indication and ECMO implantation itself is rapid (approximately 15 minutes), the overall time from collapse to ECMO initiation is relatively long (over 60 minutes). It is this time, i.e. the duration of low organ perfusion during CPR, that may be the key parameter in determining the overall neurological outcome of treatment and prognosis of patients. Shortening this interval by having the ECMO team go to well-defined OHCA cases simultaneously with the ambulance car of the Emergency Department and connecting the patient to ECMO already in the field may lead to an improvement in the neurological outcome of the treatment of OHCA patients. In many locations abroad, this model is already used, and patients are connected to ECMO already in the field. Whether the model of field ECPR can be used in the Moravian-Silesian Region depends on a number of variables. These include the logic of information acquisition and selection of suitable patients, the logic of transporting the team and material to the scene, and the logic of connection with the provision of a safe and suitable environment for the ECMO implantation itself. The goal of this study is to validate the feasibility of the method on a simulated ECPR OHCA and further implant the mobile ECPR project in the Moravian-Silesian region.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Observed collapse and presumption of cardiac cause of cardiac arrest
- •Estimated age up to 70 years
- •Baseline rhythm of ventricular fibrillation or pulseless electrical activity (PEA)
- •Basic bystander cardiopulmonary resuscitation (CPR), "bystander CPR", telephone assisted CPR (TANR)
排除标准
- •Children or adults with estimated weight below 40 kg
- •Known major comorbidities of the patient suggesting low rehabilitation potential (e.g. chronic obstructive pulmonary disease (COPD) IV, malignancy in tertiary phase)
结局指标
主要结局
Time from cardiac arrest (collapse) to implantation of ECMO
时间窗: up to 60 minutes
The time from cardiac arrest (collapse) to implantation of ECMO will be recorded and assessed
Hospital mortality
时间窗: up to 3 weeks
Hospital mortality will be assessed for the period of 3 weeks
Cerebral Performance Category (CPC) score
时间窗: 30 days
Cerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest
Neurological outcome (CPC score)
时间窗: 6 months
Neurological outcome will be assessed using the Cerebral Performance Category Scale (CPC) 6 months after cardiac arrest.
Neurological outcome (SF-36)
时间窗: 6 months
Neurological outcome will be assessed using the Short Form 36 Health Subject Questionnaire (SF-36) 6 months after cardiac arrest.
Neurological outcome (EQ-5D)
时间窗: 6 months
Neurological outcome will be assessed using the European Quality of Life Questionnaire (EQ-5D) 6 months after cardiac arrest.
次要结局
未报告次要终点
