Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-Inferiority Trial in Patients With Exercise Induced Desaturation Due to Chronic Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 SOT in subjects with chronic lung disease in submaximal exercise.
详细描述
Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at 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.
Our 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 chronic lung disease
- •Former desaturation under exercise defined as Spo2-decrease >3%- Page 3 of 4
- •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 Oxygen (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.
研究组 & 干预措施
Ambient air
Patient will perform tests at University Hospital Zurich on ambient air
干预措施: 6-minute walk distance (6MWD) test on ambient air (Other)
SOT via basal cannula
Supplemental Oxygen Therapy (SOT) will be provided via nasal cannula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.
干预措施: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal) (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: after 6 minutes
Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
次要结局
- Blood pressure at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)
- SpO2 at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)
- Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air(6 minutes)
- Heart rate at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)
- Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air(after 6 minutes)