ACTRN12615001119583尚未招募未知
A feasibility study on the effect of target temperature management on patient temperature in traumatic brain injury patients.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Age greater than or equal to 16
- •2.Blunt trauma with clinical diagnosis of TBI defined as:
- •a.Blunt head trauma
- •b.Glasgow Coma Scale (GCS) score less than or equal to 13 (prior to sedation)
- •c.Computed tomographic (CT) scan of the head consistent with traumatic brain injury
- •3.Invasive mechanical ventilation and predicted need for invasive mechanical ventilation beyond the next calendar day.
- •4.Screening and randomisation within 24 hours of injury
排除标准
- •1.The treating physician intends to control temperature and/or induce hypothermia as part of the management plan
- •2.The treating clinician deems participation is not in the patient’s best interests
- •3.Drug or alcohol intoxication is likely to be the predominant cause of coma
- •4.Cardiac arrest at scene of injury
- •5.Spinal cord injury with confirmed neurological deficit
- •6.Pregnancy
- •7.Disability prior to injury, defined by a score of 4 or less as assessed by the extended Glasgow Outcome Score
- •8.Death is deemed to be imminent/inevitable or a treatment limitation order is in place
- •9.The patient has an underlying process or comorbidity making 180-day survival unlikely
研究者
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