NCT02599246已完成不适用
Measured FiO2 With Nasal Canula O2 Versus Noninvasive Ventilation (NIV) With the Same O2 Flow, in COPD Patients the NIV LEAKS Study
Breas Medical S.A.R.L.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年11月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow
研究概览
简要总结
The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.
详细描述
in a prospective observational study the investigators will register FiO2 in 15 voluntaries COPD patients as following:
- Pharyngeal FiO2 (G5® Philips™ side stream FiO2) with O2 supply through nasal cannula at basal flow (flow needed by patient). In order to compare FiO2s the investigators will measure FiO2 with 150%, 75%, 50% and 25 % of basal Flow
- And FiO2 during nocturnal NIV (pressure support ventilation; Vivo 50®, Bréas™), using facial or nasal masque (Confort Gel® Respironics™). O2 flow will be basal flow.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
排除标准
- •acute on chronic respiratory distress
结局指标
主要结局
Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow
时间窗: 18 hours
次要结局
- Time spent below different O2 levels during NIV despite constant O2 flow and their correlation to day time FiO2 with nasal canula(18 hours)
- levels of O2 adjustment needed to keep FiO2 stable with NIV(1 hour)
研究者
研究点 (1)
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