Effect of Supplemental Oxygen Therapy (SOT) in Patients With Pulmonary Vascular Diseases (PVD) Defined as Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension (PH) Who Permanently Live >2500m on Pulmonary Artery Pressure (PAP) and Other Hemodynamics by Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Pulmonary Artery Pressure with SOT vs. placebo
研究概览
简要总结
To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.
详细描述
Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.
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
- Single (Participant)
盲法说明
Sham SOT (placebo, ambient hypoxic air at 2840m) versus high-flow oxygen 10l/min both via a facial mask with reservoir will be applied
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
- •Adult patients 18-80 years old of both genders,
- •Residence > 2500m of altitude
- •diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- •Patients stable on therapy
- •New York Heart Association (NYHA) functional class I-III
- •Provided written informed consent to participate in the study.
排除标准
- •Age <18 years or >80 years
- •unstable condition
- •Patients who cannot follow the study investigations, patient permanently living < 2500m.
- •Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- •Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) <80% on ambient air.
- •Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)
- •Patient with a non-corrected ventricular septum defect
- •Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
结局指标
主要结局
Change in Pulmonary Artery Pressure with SOT vs. placebo
时间窗: at 15 min of breathing ambient air or supplemental oxygen
Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
次要结局
- Change in ph by arterial blood gases with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in right atrial area with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in right heart strain with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in PaO2 by arterial blood gases with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in Cardiac Output with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in right to left heart diameter ratio with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)
- Change in PaCO2 by arterial blood gases with SOT vs. placebo(at 15 min of breathing ambient air or supplemental oxygen)