A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- 30 days mortality after injury or illness.
研究概览
简要总结
This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.
详细描述
The ELITE trial is a prospective randomized controlled trial (RCT) to compare competent EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) < 9 and short ambulance transport times (< 20 min) to hospital.
The study aims to establish if advanced airway management with endotracheal intubation (ETI) in the field by specially trained Emergency Medical Services (EMS) physicians - compared to endotracheal intubation (ETI) performed by physicians in the emergency department in the same group - improves outcome in terms of 30-day mortality, degree of disability at discharge, complications and length of hospital stay, and neurologic outcome at 6 months.
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
- •Adult patients (> 18 years)
- •Initial GCS < 9 independent of cause.
- •Intact airway reflexes and no impending airway obstruction.
- •Located < 20 min ambulance transport time from nearest hospital emergency department.
排除标准
- •Pediatric patients (under 18 years).
- •Primary cardiorespiratory arrest (of non-traumatic / medical cause).
- •Planned helicopter transport to hospital.
结局指标
主要结局
30 days mortality after injury or illness.
时间窗: 30 days after illness or injury
Dead or alive
Neurologic outcome at 6 months after injury or illness.
时间窗: 6 months after illness or injury
Neurologic outcome will be assessed using glascow outcome scores (GOS-E)
次要结局
- Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax).(up to 6 months after illness or injury)
- Intubation success rates and airway management complications for the entire cohort and for key subsets(up to 6 months after illness or injury)
- Length of hospital stay, complications and degree of disability at discharge.(up to 6 months after illness or injury)