A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- neurescue
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Resuscitation
研究概览
简要总结
The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.
The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.
The purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.
详细描述
Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.
The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.
Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.
The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 and ≤80 years
- •Witnessed arrest
- •CPR initiated within 7 min of arrest
- •CPR time less than 40 min at enrollment
- •Non-shockable rhythm
排除标准
- •Traumatic cardiac arrest
- •Known pregnancy
- •Known terminal disease
- •Known do-not-attempt-CPR order
- •Known opposition to study participation
结局指标
主要结局
Resuscitation
时间窗: Measured from 10 minutes after randomization to 70 minutes after randomization
Subject achieving shockable rhythm or ROSC
次要结局
- Epinephrine(Measured from 10 minutes after randomization to 70 minutes after randomization)
- Procedures(Measured from 10 minutes after randomization to 90 days post cardiac arrest)
- CPC score(Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest)
- (S)A(D)E(Measured from randomization to 90 days post cardiac arrest)
- EQ-5D(Measured 90 days post cardiac arrest)
- Survival(Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest)