NCT05146661已完成不适用
An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to 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
- 10
- 试验地点
- 4
- 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 balloon catheter for aortic 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 to redirect blood flow towards the upper body.
The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤79 years
- •Witnessed cardiac arrest
- •CPR initiated within 7 min of presumed arrest
- •Cardiac arrest not responding to standard ALS
- •Total CPR time ≤ 40 min at the time of screening for enrollment
排除标准
- •Traumatic cardiac arrest
- •Known pregnancy
- •Known terminal disease
- •Known Do-Not-Resuscitate (DNR) 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
- Time from first vessel puncture to successful sheath insertion(From first needle stick to successful sheath insertion)
- Rate of occlusion success(Assessed up to 1 hour)
- Return of spontaneous circulation (ROSC)(Assessed up to 1 hour)
- Change in central blood pressure(At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation)
- Total ALS time at initiation of the investigational procedure(From initiation of ALS to initiation of the investigational procedure)
- Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment(From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)Cardiopulmonary ArrestCardiovascular DiseasesCardiac ArrestNCT05444049neurescue6
已完成
不适用
Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory FailureRespiratory FailureNCT00603174St. Justine's Hospital10
撤回
不适用
Electrically Guided Needle Insertion: ICU StudyPercutaneous TracheostomyNCT01522027University of Alberta
招募中
1 期
Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its ComorbiditiesDiabetes Mellitus, Type 2HypertensionNCT05363761Neurotronic, Inc.50
进行中（未招募）
不适用
ENSAYO PILOTO CON IMATINIB PARA PACIENTES CON NEUROFIBROMA PLEXIFORME ASOCIADO A LA NEUROFIBROMATOSIS TIPO I. PILOT STUDY WITH IMATINIB FOR PLEXIFORM NEUROFIBROMA IN NEUROFIBROMATOSIS TYPE I PATIENTSTratamiento de los neurofibromas plexiformes de alto riesgo no abordables quirúrgicamente en pacientes con neurofibromatosis tipo IEUCTR2009-016922-15-ESHOSPITAL SANT JOAN DE DÉ