Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
研究概览
简要总结
The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
详细描述
Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.
The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Minimum 18 years of age
- •Written informed consent
- •Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
- •Former desaturation under exercise defined as Spo2-decrease >3%
- •Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)
排除标准
- •Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)
- •Pregnancy
- •Unability or contraindications to undergo the investigated intervention
- •Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
结局指标
主要结局
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
时间窗: after 6 minutes
Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
次要结局
- SpO2 at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)
- Heart rate at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)
- Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air(6 minutes)
- Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air(6 minutes)
- Blood pressure at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)