Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Flow Oxygen Therapy in Patients With Exercise Induced Desaturation Due to Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 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 liquid oxygen therapy (4l/min, nasal) )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 nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under 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), chronic obstructive pulmonary disease (COPD) with emphysema, COPD without emphysema, or interstitial lung disease
- •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 PaO2 < 6.9 kPa
- •Inability or contraindications to undergo the investigated intervention
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability etc.
研究组 & 干预措施
Ambient air
Patient will be assessed at University Hospital Zurich
干预措施: 6-minute walk distance (6MWD) test on ambient conditions (Other)
Liquid oxygen therapy via nasal canula
Supplemental Liquid Oxygen Therapy (LOX) at approximately 4l/min will be provided via nasal canula from a small oxygen tank at University Hospital Zurich to perform clinical assessments.
干预措施: 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) (Other)
结局指标
主要结局
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
时间窗: Distance will be measured at the end of 6 minutes from the 6MWT
Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air
次要结局
- SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(after 6 minutes)
- Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(after 6 minutes)
- Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air(after 6 minutes)
- Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(after 6 minutes)
- Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(after 6 minutes)
- SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(6 minutes)
- Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(6 minutes)
- Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(6 minutes)
- Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air(6 minutes)
研究者
Silvia Ulrich Somaini
Prof. Dr. med.
University of Zurich