The Relationship Between the Use of a Continuous a Zero-heat Flux Temperature Monitor on Initial Discharge Hypothermia Rate Among Severely Injured Trauma Patients: a Randomized Controlled Trial. (RUZIT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Hypothermic (<36°C) upon discharge from the trauma bay
研究概览
简要总结
Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients >18 years of age
- •Severely injured trauma patients with a Revised Trauma Score (RTS) ≤ 11 brought into the SHSC TB.
排除标准
- •Patients with blast injuries to the face or severe facial trauma will be excluded.
- •Major burn patients - as they follow a separate care pathway at SHSC
结局指标
主要结局
Hypothermic (<36°C) upon discharge from the trauma bay
时间窗: Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Proportion of patients who are hypothermic (\<36°C) upon discharge from the trauma bay.
次要结局
- 30 day mortality(Time of admission to discharge or up to 30 days after admission (whichever comes first))
- Warming initiatives(Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first))
- Length of stay(Time of admission to discharge or up to 1 year after admission (whichever comes first))
- Transfused products(Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first))
研究者
Dr. Asim Alam
MD, FRCPC
Sunnybrook Health Sciences Centre
