Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- Glasgow Outcome Scale Score
研究概览
简要总结
The study hypothesis is that advanced interventions as provided by a physician at an accident scene will decrease the death rate and the rate of severe disability in survivors of severe head injury. Extended interventions by advanced level prehospital providers may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
详细描述
A randomised, controlled trial examining prehospital management of persons with severe blunt head injury, in the Sydney region. Treatments examined will be the current system consisting principally of paramedic management (standard care) compared with management by a retrieval team lead by a consultant anaesthetist, emergency physician or intensive care specialist. Patients for inclusion in the study will be identified by a paramedic screening all "000" calls to the ambulance service and identifying persons likely to have severe head injury. The principal outcome measure will be their degree of disability measured at 6 months post injury.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale score of 3 to 8 due to blunt trauma as measured at the accident scene by the first prehospital team to arrive at the site.
排除标准
- •Penetrating trauma
- •Age less than 16 years
- •No more than 5 casualties at the scene
结局指标
主要结局
Glasgow Outcome Scale Score
时间窗: Six months post injury
次要结局
- Length of hospital and intensive care unit stays(At hospital discharge)
- 30 day survival and survival to discharge from the acute care hospital(At hospital discharge and 30 days)
- Extended Glasgow Outcome Scale Score(Six months post injury)
- Disability Rating scale(Six months post injury)
研究者
Alan Garner
Medical Director
CareFlight