NCT00557752终止4 期
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
Hospital Virgen de la Salud4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Intubation rate
研究概览
简要总结
- Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
- Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
- The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
- As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age > 18 years.
- •Informed consent obtained.
- •pO2/FiO2 <200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.
排除标准
- •Orotracheal intubation indicated for any other reason.
- •Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
- •Severe traumatic brain injury.
- •Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
- •Cervical injury with specific treatment contraindicating a facial mask.
- •Bronco-pleural fistula.
- •Gastro-intestinal trauma.
结局指标
主要结局
Intubation rate
时间窗: 1 month
次要结局
- Intensive Care Unit stay(2 months)
- Pneumothorax rate(1 month)
- Pneumonia rate(1 month)
研究者
研究点 (4)
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