Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,086
- 试验地点
- 1
- 主要终点
- Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)
研究概览
简要总结
The purpose of this study is to demonstrate that the specific management will increase the number of alive trauma patient arriving with a temperature > 35°C.
详细描述
Trauma patients are often hypothermic (temperature < 35 °C) upon arrival at the hospital. Hypothermia is with hypotension and hypoxia, perfectly known to be directly responsible for complications.
Hypothermia is responsible, with acidosis and coagulopathy, of the " lethal triad" of trauma.
Thus, it is clearly established that hypothermia is directly associated with poor prognostic in trauma patients. In a recent study, mortality rate reached 100% for trauma patients arriving at the hospital with a body temperature below 32°C.
The weather, the severity of the trauma and medical (or paramedical) interventions are responsible for the onset of this hypothermia.
Then, continuous monitoring of the patient's temperature, active protection against hypothermia with a metal blanket, the warming (and measure the temperature of) infusion fluids, the warming (and measure the temperature of) the ambulance should improve patient's outcome. As hypothermia is associated with mortality of trauma patients, the control must lead to reduce mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient with trauma (> 18 years)
- •Pre-hospital management by MICU
- •Scheduled transfer to a receiving center by a MICU
- •And at least one of the following criteria :
- •Ambient temperature on the field < 18°C
- •Body temperature <35°C on MICU arrival
- •A Glasgow score < 15 on MICU arrival
- •Systolic blood pressure < 100 mm Hg on MICU arrival
排除标准
- •Body temperature <31°C or >38°C
- •Cardiac arrest before MICU arrival
- •Bilateral ear bleeding preventing continuous monitoring of tympanic temperature
研究组 & 干预措施
1: control group
Classic - current management of trauma patients by French medical teams
干预措施: 1: control group (Other)
2: interventional group
Intervention Name : monitoring, treatment, control and prevention of hypothermia
- Continuous monitoring of body temperature
- Ambulance warming (target : 30°C)
- Patient warming with dedicated blanket
- Infusion fluid warming (and temperature control)
干预措施: 2: interventional group (Other)
结局指标
主要结局
Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)
时间窗: Day0
次要结局
- Length of stay at hospital (days)(up to 3 months)
- Survival at hospital discharge(up to 3 months)