Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
研究概览
简要总结
Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room.
Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia .
It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients.
The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Major patient with all-cause trauma Grade A or B
- •Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.
排除标准
- •Patient initially supported by a pre-hospital medical team who does not participate in the study,
- •Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
- •Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
- •Patient with inguinal crease or subclavicular fossa injury,
- •Patient with severe burn (Burnt Body Surface> 20%),
- •Patient deprived of liberty including patients with an electronic bracelet.
结局指标
主要结局
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
时间窗: 4 hours
Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.
次要结局
- Evaluation of mortality(72 hours)
- Proportion of patients with coagulopathy on arrival at the emergency room.(4 hours)
- Evaluation of mortality (cardio respiratory arrest)(72 hours)
- Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.(4 hours)
- Loss of heat due to a drop of temperature(4 hours)
- Proportion of patients with acidosis on arrival at the emergency room.(4 hours)
- Evaluation of mortality (deaths before admission )(72 hours)
- First degree burn(4 hours)
- Patient feels cold(4 hours)