Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 6
- 主要终点
- acute hypercapnic respiratory failure episode
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. 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 acute hypercapnic respiratory failure episode treated by non invasive ventilation.
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
- •COPD patients who survived after an acute episode of hypercapnic respiratory failure
- •patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg
排除标准
- •severe obstructive sleep apnea ( DI > 30/h)
- •Non COPD cause of respiratory failure
- •Serious comorbidity
- •Adverse psychological status
研究组 & 干预措施
Long Term Oxygen Therapy alone
Long Term oxygen therapy is prescribed according to the guidelines
Non invasive ventilation
Home non invasive ventilation is prescribed with the following settings
- PS mode
- IPAP according to clinical and hemodynamic tolerance
- EPAP according to air trapping
- RR around 12/ min.
- LOT for SaO2 > 90%
- Monitoring with capnometry for settings validation
干预措施: Home ventilator (Device)
结局指标
主要结局
acute hypercapnic respiratory failure episode
时间窗: up to 24 months
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
次要结局
- acute hypercapnic respiratory failure episode rate(up to 24 months)
- pulmonary function test(at one month and every six months up to 24 months)
- Six Minute Walk Distance(at one month and every six months up to 24 months)
- Quality of life(at one month and every six months up to 24 months)
- Heart function(at one month and every six months up to 24 months)
- Cost effectiveness(at one month and every six months up to 24 months)
- mortality(at one month and every six months up to 24 months)
- arterial blood gas(at one month and every six months up to 24 months)
研究者
BOUCHRA LAMIA
Professor of medecine, pulmonology. MD, MPH, PhD
University Hospital, Rouen