NCT03299764暂停不适用
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
Research Center Borstel10 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2017年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- Walking distance in 6-minutes walking test
研究概览
简要总结
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
详细描述
Intervention:
Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age >40 years
- •COPD diagnosis known for at least 12 months
- •NIV therapy for at least 3 months
- •4. Regular use of NIV with extrapolated usage time of at least 700 hours / year
- •Current inspiratory NIV pressure ≥20 mbar
- •Patient understands the requirements of the study
- •Patient is able to follow the study protocol
排除标准
- •Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- •Radiologically proven pneumonia within the past month
- •Other leading pulmonary illness
- •Tracheostomy
- •Pneumothorax
- •Pregnancy or lactation
- •BMI >35 kg/m²
- •Steroid therapy with >15 mg prednisolon daily for >1 month
- •Condition causing hypercapnia other than COPD
- •6MWT distance of >300 meters within the last 7 days
- •Previous therapy with the Vigaro NIV device
- •Weight loss of more than 5 kg / 12 months
- •Further criteria to exclude confounding factors
结局指标
主要结局
Walking distance in 6-minutes walking test
时间窗: 3 months
次要结局
- Mortality(12 months)
- Number of hospital admissions(12 months)
研究者
研究点 (10)
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