试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- neurescue
- 主要终点
- Central blood pressure
研究概览
简要总结
Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.
The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
详细描述
The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.
Data collected:
- from enrolment of the patient until hospital arrival
- every 24 hours
- at discharge or 7 days post enrollment
- at 30 days post enrollment
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Witnessed cardiac arrest
- •Bystander or professional CPR within 5 minutes
- •Refractory cardiac arrest
排除标准
- •End Tidal CO2 <1,3 kPa
- •Traumatic cardiac arrest
- •Women with known pregnancy
- •Patients with known terminal disease
- •Patients with known do-not-attempt-CPR order
- •Patients with overdose
结局指标
主要结局
Central blood pressure
时间窗: 1 hour
次要结局
- Changes in cardiac rhythm following balloon inflation(1 hour)
- During procedure - time from first needle stick to successful sheath insertion(1 hour)
- During procedure - time from first needle stick to finalized balloon inflation(1 hour)
- Return of spontaneous circulation (ROSC)(1 hour)
- End-tidal CO2 (EtCO2)(1 hour)