German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- breathing frequency
研究概览
简要总结
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.
Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable respiratory situation
- •Clinically required NIV
- •Capable of giving consent
排除标准
- •Invasive ventilation
- •Any other severe physical disease that requires immediate medical assistance
- •Acute hypercapnic decompensation with pH <7.30 in routine BGA
- •Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
- •Participation in a clinical trial within the last 4 weeks
- •Pregnancy or nursing period
- •Drug addiction
研究组 & 干预措施
bilevel ventilation BIPAP ST
one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.
干预措施: BIPAP ST (Device)
BIPAP ST plus Airtrap
one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.
干预措施: BIPAP ST (Device)
BIPAP ST plus Airtrap
one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.
干预措施: Airtrap (Device)
结局指标
主要结局
breathing frequency
时间窗: 2 nights
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
次要结局
- mean pCO2 level(2 nights)
研究者
Georg Nilius
Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie
Institut für Pneumologie Hagen Ambrock eV