DRKS00012325招募中未知
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
Forschungszentrum Borstel0 个研究点目标入组 256 人开始时间: 2017年8月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- All
入选标准
- •1. Age >40 years
- •2. COPD diagnosis known for at least 12 months
- •3. NIV therapy for at least 3 months
- •4. Regular use of NIV with extrapolated usage time of at least 700 hours / year
- •5. Current inspiratory NIV pressure =20 mbar
- •6. Patient understands the requirements of the study
- •7. Patient is able to follow the study protocol
排除标准
- •1.Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- •2.Radiologically proven pneumonia within the past month
- •3.Other leading pulmonary illness
- •4.Tracheostomy
- •5.Pneumothorax
- •6.Pregnancy or lactation
- •7.BMI >35 kg/m²
- •8.Steroid therapy with >15 mg prednisolon daily for >1 month
- •9.Condition causing hypercapnia other than COPD
- •10.6MWT distance of >300 meters within the last 7 days
- •11.Previous therapy with the Vigaro NIV device
- •12.Weight loss of more than 5 kg / 12 months
- •13.Further criteria to exclude confounding factors
研究者
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