Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 7
- 主要终点
- cooling rate at 0.5 hours
研究概览
简要总结
The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:
- the cooling rate of cooling blanket in patients with heat stroke
- the relationship between cooling blanket and outcomes in patients with heat stroke
Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.
Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •≥ 18 years old
- •diagnosed as heat stroke
- •informed consent of patients or family members
排除标准
- •need immediate cardiopulmonary resuscitation
- •body temperature <39.5℃ on admission
- •with the underlying disease of severe organ damage
- •pregnant women
研究组 & 干预措施
non-cooling blanket group
Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc.
干预措施: non-cooling blanket (Device)
Cooling blanket group
On the basis of the cooling methods of non-cooling blanket group, combine the cooling blanket to cool down. The cooling blanket is required to be activated within 30min after admission. The blanket temperature will be set at 4-10℃, and the target body temperature is 38℃.
干预措施: cooling blanket (Device)
结局指标
主要结局
cooling rate at 0.5 hours
时间窗: 0.5 hours
The cooling rate of 0.5h was calculated by the initial temperature and the 0.5 hours temperature.
Body temperature of 0.5 hours
时间窗: 0.5 hours after admission to emergency department
Body temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.
次要结局
- Body temperature of 2 hours(2 hours)
- incidence of organ damage(up to 90 days)
- length of ICU stay(up to 90 days)
- in-hospital mortality(up to 90 days)