NCT01915719已完成不适用
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- Day 28 Mortality
研究概览
简要总结
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •ICU admission
- •Acute respiratory failure defined by (PaO2<60 mmHg at room air) or (polypnea >30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.
- •Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid > 1mg/kg/d or >1 month or other immunosuppressive treatment >1 month)
排除标准
- •Hypercapnia >50 mmHg or increased of hypercapnia >10 mmHg under Oxygen treatment
- •Need of immediate mechanical ventilation
- •Obvious cardiogenic oedema
- •Vasopressor use >0.03 µg/kg/min
- •Glasgow Score <13
- •End of life decision
- •Acute myocardial infarction
- •Patient refusal
- •Pregnancy
- •No national health insurance
结局指标
主要结局
Day 28 Mortality
时间窗: Day 28
次要结局
- Nosocomial infection(day 28)
- Length of stay in ICU(Day 28)
- Needs of mechanical ventilation(Day 28)
- SOFA Score(Hour 72)
- performance status (OMS scale ranging from 0-perfect status- to 4-moribund)(6 Months)
研究者
研究点 (2)
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