Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- mortality rates
研究概览
简要总结
The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.
详细描述
Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyspnea with respiratory rates higher than 35 p.m.
- •pO2 < 65 mmHg
- •paO2/FiO2 < 250
排除标准
- •respiratory or cardiac arrest
- •gastrointestinal bleeding
- •hemodynamic instability
- •face surgery
- •upper airway obstruction
- •inability for active cooperation
- •need for airway protection
- •exacerbation of COPD
- •decrease of conscious level
- •acute pulmonary cardiogenic oedema
结局指标
主要结局
mortality rates
时间窗: patient hospital discharge
次要结局
- oxygenation improve(patient hospital discharge)
- diminishing of tracheal intubation incidence(patient hospital discharge)
- ICU and Post ICU hospital length of stay(patient hospital discharge)