NCT01748474已完成2 期
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Watt
研究概览
简要总结
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pulmonary arterial hypertension class I and IV (according to the latest WHO classification scheme of Dana Point 2008)
- •on optimized medical therapy and in stable condition for at least 4 week
- •desaturate in the 6 minute walking test by at least 4% to values <92%
排除标准
- •unstable conditions
- •pregnant women
- •patients with pulmonary venous hypertension
- •patients with relevant concomitant lung disease and severe daytime hypoxemia
研究组 & 干预措施
Supplemental oxygen
Experimental
Supplemental oxygen will be applied via a mask during CPET
干预措施: Supplemental oxygen via a mask (Procedure)
Sham room air
Placebo Comparator
Room air will be applied similarly to oxygen
干预措施: Supplemental oxygen via a mask (Procedure)
结局指标
主要结局
Watt
时间窗: 1 day
exercise time
时间窗: 1 day
次要结局
- end-tidal pressures of carbon dioxide (PET CO2)(1 day)
- Peak oxygen uptake(1 day)
- Respiratory exchange ratio(1 day)
- ventilatory equivalent of carbon dioxide (VE/VCO2) slope(1 day)
- Changes in arterial blood parameters(1 day)
研究者
研究点 (1)
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