CPReboa: In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Sustained ROSC
研究概览
简要总结
This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.
详细描述
Patients with in-hospital cardiac arrest (IHCA) outside the operating room, the coronary angiography suite and the intensive care unit (ICU) will be attended to by the hospitals resuscitation team and provided with advanced cardiac life support (ACLS) as per usual practice.
A research team will be deployed simultaneously and, when patients meet inclusion criteria, will randomize patients to ACLS alone or to ACLS plus balloon occlusion of the descending thoracic aorta by means of a resuscitative endovascular occlusion of the aorta (REBOA) catheter.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
- •successful placement of a femoral artery introducer sheath
- •any electrical cardiac activity seen in the initial rhythm analysis
- •ongoing effort of resuscitation as determined by study-independent resuscitation lead
排除标准
- •IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
- •hospital visitors suffering from cardiac arrest
- •asystole seen in the initial rhythm analysis
- •(presumed) age under 18 years
- •known "do not resuscitate"-order
- •known or obvious pregnancy
- •traumatic cardiac arrest
- •known aortic pathologies that render cannulation impossible
- •known allergies to radiographic contrast agents
研究组 & 干预措施
Advanced Cardiac Life Support (ACLS) alone
Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR).
干预措施: Advanced Cardiac Life Support (ACLS) (Other)
Advanced Cardiac Life Support (ACLS) plus REBOA
Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA).
干预措施: resuscitative endovascular occlusion of the aorta (REBOA) (Device)
Advanced Cardiac Life Support (ACLS) plus REBOA
Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA).
干预措施: Advanced Cardiac Life Support (ACLS) (Other)
结局指标
主要结局
Sustained ROSC
时间窗: Up to 1 hour after study inclusion
Any return of spontaneous circulation lasting longer then 20 minutes
次要结局
- Survival to hospital discharge(at hospital discharge, up to 90 days after study inclusion)
- Survival to six month(6 month after study inclusion)
- neurologic outcome at the time of 30 days(Day 30 after study inclusion)
- neurologic outcome at the time of six month(6 month after study inclusion)
- ICU-free days before hospital discharge(at hospital discharge, up to 90 days after study inclusion)
- ICU-free days at 30 days(30 days after study inclusion)