A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
研究概览
简要总结
The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.
Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.
Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).
This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.
详细描述
This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial.
Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.
The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients.
If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.
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 (Outcomes Assessor)
盲法说明
Blinded from the statisticians who carry out analyses
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •out-of-hospital cardiac arrest
- •non-traumatic cardiac arrest
- •less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support
- •advanced cardiac life support is established and can be continued
排除标准
- •traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches
- •accidental hypothermia with temperature < 32 0C
- •suspected cerebral hemorrhage as etiology of the arrest
- •suspected non-traumatic hemorrhage as etiology of the arrest
- •pregnancy, obvious or suspected
- •patient included to the study site's E-CPR protocol
- •other factors as decided by the treatment team (environmental factors, safety factors and others)
研究组 & 干预措施
Control group - ACLS
Advanced cardiovascular life support as described in the guidelines
干预措施: usual procedure according to guidelines (Procedure)
Intervention group - REBOA
Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved
干预措施: REBOA (Procedure)
Intervention group - REBOA
Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved
干预措施: usual procedure according to guidelines (Procedure)
结局指标
主要结局
Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
时间窗: 60 minutes
Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.
次要结局
- The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.(30 days)
- Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.(15 minutes)
- Change in blood pressures after aortic occlusion(15 minutes)
- Difference in left ventricular ejection fraction (LVEF) measured by echocardiography(1-2 weeks)