Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. "Prague OHCA Study"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Composite endpoint of survival with good neurological outcome (CPC 1-2).
研究概览
简要总结
Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.
详细描述
Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.
Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, ECLS and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care.
Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.
Standard postresuscitation care will follow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •minimum of 18 and maximum of 65 years
- •witnessed out-of-hospital cardiac arrest of presumed cardiac cause
- •minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC
- •unconsciousness (Glasgow Coma Score < 8)
- •ECMO team and bed-capacity in cardiac center available.
排除标准
- •OHCA of presumed non-cardiac cause
- •unwitnessed collapse
- •pregnancy
- •sustained ROSC within 5 minutes of ACLS performed by EMS team
- •conscious patient
- •known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
- •suspected or confirmed acute stroke
- •known severe chronic organ dysfunction or other limitations in therapy
- •"do not resuscitate" order or other circumstances making 180 day survival unlikely
- •known pre-arrest cerebral performance category CPC ≥ 3.
结局指标
主要结局
Composite endpoint of survival with good neurological outcome (CPC 1-2).
时间窗: 6 months
次要结局
- Cardiac recovery(30 days)
- Neurological recovery(30 days)
研究者
Jan Belohlavek
Jan Belohlavek, MD, PhD., Consultant in Cardiology and Critical Care
Charles University, Czech Republic