Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of hospital acquired pneumonia from randomization to study day 90
研究概览
简要总结
The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.
详细描述
Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Guillain Barré Syndrome
- •Age of 18 years old or more
- •Inability to lift head
- •Time from onset of motor deficit less than 7 days
- •Written informed consent
排除标准
- •Glasgow coma score of less than 8
- •Unstable hemodynamic status
- •Current pneumonia
- •Pregnancy
结局指标
主要结局
Rate of hospital acquired pneumonia from randomization to study day 90
时间窗: Day 90
次要结局
- Hospital length of stay(Day 90)
- Tolerance(Day 90)
- Intensive care unit lenght of stay(Day 90)
- Time on a ventilator(Day 90)
研究者
Djillali Annane
Professor in medicine
University of Versailles