Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- complications and feasibility of endovascular cooling device
研究概览
简要总结
Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients.
详细描述
We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices. Internal cooling catheter, "ICY" , and thermal regulator device, "Coolguard 2000" are applied to the patients from femoral vein. WE definite 4 stages according to the temperature during the clinical trial: "The Cooling Phase", "Hypothermia phase", "Rewarming phase", and "Postrewarming phase". The temperature is lowed or elevated by the rate 0.5C/hr during the Cooling and Rewarming Phase, and it is maintained 33 +/- 1 C during hypothermia phase for 12 hours according to the comment of ACLS. To understand the safety and feasibility, regular blood sampling, bedside EEG and vital monitors, and special sheets are designed to document the every reasons, time points or every clinical events during hypothermia therapy. The patients is observed until rewarming finish for 48 hours or till death if expired during post-resuscitation hypothermia therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points.
排除标准
- •Age > 78 y/o or < 18 y/o
- •Core temperature< 34℃or > 38 ℃ after resuscitation
- •Underline terminal malignancy disorder or refuse aggressive treatment cancer patient
- •Massive bleeding, known coagulopathy, or received regular anticoagulant medication
- •Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents
- •No bed available in ICU
结局指标
主要结局
complications and feasibility of endovascular cooling device
次要结局
未报告次要终点