CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in core body temperature by 1 degree Centigrade.
研究概览
简要总结
Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.
The device is a prototype cooling vest. The investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree Centigrade an hour to initiate cooling. What the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. That means some of the initial prototypes will not resemble what we expect the eventual device to look like. The investigators will be undertaking the initial trials on 30 normal volunteers.
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 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Human volunteers aged over
- •The upper age limit, as is standard for risk mitigation in such studies, is
- •The volunteer must have capacity to understand the trial and give informed consent to participate. If the volunteer's first language is not English we will make use of Sussex Interpreting Services, a professional interpreting service.
排除标准
- •Pregnancy. Any disclosed medical condition. Any medical condition detected on examination. Core temperature outside stated parameters.
- •We will ask the volunteer to confirm that they are otherwise healthy, taking no regular medication (except the oral contraceptive pill), are not using recreational drugs and have no significant past medical history, in particular cardiovascular disease of any sort, thyroid disease, diabetes mellitus or other metabolic disease.
研究组 & 干预措施
Cooling
干预措施: Cooling (Device)
结局指标
主要结局
Reduction in core body temperature by 1 degree Centigrade.
时间窗: 1 hour.
The cooling properties of the vest are under investigation, and this reduction is the primary outcome measure.
次要结局
- Skin condition.(3 days.)
- Sepsis.(3 days.)
- ECG abnormalities.(3 hours.)
