Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- six minute walk distance
研究概览
简要总结
Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.
This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.
详细描述
Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.
The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Confirmed diagnosis of COPD in stages GOLD IV
- •Receiving optimized medical treatment and long term oxygen treatment, if indicated
- •Patient's consent to participate in this trial
排除标准
- •Previous treatment with NIPPV
- •Unwillingness or intolerance to perform NIPPV
- •Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,
- •Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training
- •Poor controlled coexisting psychiatric or unstable cardiac disease,
- •Inability to perform a six minute walk test
- •Extreme hypercapnia (pCO2 > 74 mmHg)
结局指标
主要结局
six minute walk distance
时间窗: beginning to end of rehabilitation
次要结局
- quality of life(beginning to end of rehabilitation)