Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to successful deployment of device
研究概览
简要总结
Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).
详细描述
Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device.
The aims of UPFRONT are:
- To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA
- To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.
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
盲法说明
None. Masking is not possible.
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
- •Apparent age between 18 - 70 years.
- •OHCA defined as receiving professional CPR or AED defibrillation
- •OHCA witnessed by bystanders or professional rescuers / UED personnel
- •VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA
- •Total time pulseless > 10 minutes
排除标准
- •Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living
- •Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)
- •Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest
- •Do-Not-Resuscitate order or comfort care measures in place prior to enrollment
- •Special populations (pregnant, prisoner, or cognitively impaired)
- •Total time pulseless greater than 20 minutes
- •Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since
研究组 & 干预措施
Standard Care
Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS)
Standard Care Plus Intervention
Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention
干预措施: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device (Device)
结局指标
主要结局
Time to successful deployment of device
时间窗: Up to 10 minutes
The device is successfully deployed when it raises the mean arterial pressure
次要结局
- Return of spontaneous circulation (ROSC)(Up to 60 minutes)
研究者
Michael C. Kurz
Professor and Vice Chair for Research
University of Alabama at Birmingham