NCT05444049已完成不适用
A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- neurescue
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Successful balloon inflation within 10 minutes from first vessel puncture
研究概览
简要总结
The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, 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 aorta to redirect blood flow towards the upper body.
The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •CPR initiated within 7 min of presumed arrest
- •8 min of continuous ACLS without ROSC
排除标准
- •Traumatic cardiac arrest
- •Intraoperative cardiac arrest
- •Known pregnancy
- •Known terminal disease
- •Known do-not-attempt-CPR order
- •Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
- •Subjects currently on mechanical circulatory support
结局指标
主要结局
Successful balloon inflation within 10 minutes from first vessel puncture
时间窗: Assessed up to 10 min
次要结局
- Change in central blood pressure(Assessed up to 1 hour)
- Rate of occlusion success(Assessed up to 1 hour)
- Return of spontaneous circulation (ROSC)(Assessed up to 1 hour)
- Time from first vessel puncture to successful sheath insertion(Assessed up to 1 hour)
- Total ACLS time at initiation of the investigational procedure(Assessed up to 1 hour)
研究者
研究点 (2)
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