NCT01818388已完成不适用
A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
ZOLL Circulation, Inc., USA9 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
研究概览
简要总结
A multicenter prospective single arm interventional trial in hospitals where therapeutic hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
时间窗: Day 1
次要结局
- Incident Adverse Events Defined as Safety(Up to 90 days)
- Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention(Up to 90 days)
研究者
研究点 (9)
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