Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Acute hypercapnic respiratory failure episode
研究概览
简要总结
Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •COPD patients who survived after an episode of acute hypercapnic respiratory failure
- •Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 > 55 mmHg and pH > 7.35
排除标准
- •Age > 85 years old
- •Non- COPD causes of respiratory failure
- •Obstructive sleep apnea excluded by polysomnography
- •Adverse psychosocial status
- •Serious co-morbidity
研究组 & 干预措施
Long Term Oxygen Therapy
Non Invasive Ventilation
干预措施: Non Invasive Ventilation (Device)
结局指标
主要结局
Acute hypercapnic respiratory failure episode
时间窗: up to 102 weeks
次要结局
- Death(1 month and every 6 months during 2 years)