STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Was the blanket applied to the patient?
研究概览
简要总结
This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients.
详细描述
Hypothermia (core body temperature of <36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any trauma patient requiring activation of the massive hemorrhage protocol (life- threatening bleeding situation requiring mobilization of blood bank, laboratory and clinical resources, and anticipated need for at least 4 units of red blood cells immediately and component therapy) during the hours when research staff are available. Normothermic (core body temperature between 36˚C or greater) will also be included, as core body temperature drops once resuscitation is initiated.
- •Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis da Luz/trauma fellow is on call as Trauma Team Leader will also be included.
排除标准
- •Patients known to be pregnant
- •Patients who die in the trauma bay
- •Patients excluded at the discretion of the TTL based on use of the blanket not appearing feasible given the sustained injuries, multiple procedures being conducted in the trauma, or patients who seem to have unsurvivable injuries.
- •Patients admitted during study off-hours.
结局指标
主要结局
Was the blanket applied to the patient?
时间窗: Through study completion, an average of 24 hours
Binary indication of whether or not the blanket is applied to the patient
Were patient temperatures recorded?
时间窗: Through study completion, an average of 24 hours
At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department \[ED\], or operating room), or preferentially, at the final phase of care usually the ICU or ED
Did the blanket remain on the patient?
时间窗: Through study completion, an average of 24 hours
Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)
次要结局
- Did the patient experience any redness and/or burns?(Through study completion, an average of 24 hours)
- Was the blanket placed directly on the patients skin?(Through study completion, an average of 24 hours)
- Cold Discomfort Questionnaire(Up to 2 weeks)
- Did the patients temperature exceed 38 degrees Celsius?(Through study completion, an average of 24 hours)
研究者
Luis Teodoro da Luz
Staff Physician
Sunnybrook Health Sciences Centre