NCT06489756已完成不适用
Effect of Supplemental Oxygen Therapy (SOT) on Pulmonary Arterial Pressure in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m
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 pulmonary arterial pressure (PAP) assessed at 3200 m.
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 have echocardiografy to assess PAP near their living altitude in Aksay at 3200 m with and without 10L/min supplemental oxygen therapy (SOT) via face mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m
时间窗: at 15 min of breathing ambient air or supplemental oxygen
Change in RV/RA in mmHg assessed by echocardiography with SOT compared to ambient air at 3200m
次要结局
- Change in right heart strain with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in Cardiac Output with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in right atrial area with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in pH by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in right to left heart diameter ratio with SOT vs.ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
- Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
研究者
研究点 (1)
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