Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
研究概览
简要总结
The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 3200m.
详细描述
Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) >30 mmHg will be recruited for this project. Highlanders permanently living at HA >2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanently living >2500 m
- •HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- •Written informed consent
排除标准
- •Highlanders who cannot follow the study investigations,
- •Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- •Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- •Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
结局指标
主要结局
6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
时间窗: after 6 minute
Change in 6MWD in meters between SOT vs. ambient air at 3200 m
次要结局
- Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)