Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 6 minute walk test
研究概览
简要总结
In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary 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 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.
排除标准
- •Patients in unstable conditions requiring frequent therapeutic adaption
- •pregnant women
- •patients with pulmonary venous hypertension due to left heart diseases
- •patients with relevant concomitant lung disease and severe daytime hypoxemia
研究组 & 干预措施
Supplemental oxygen
Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
干预措施: long term oxygen therapy (Procedure)
Sham room air
Room air given at a flow rate of 3 liters per minute for 16 hours a day
干预措施: long term oxygen therapy (Procedure)
结局指标
主要结局
6 minute walk test
时间窗: 5 weeks
6 minute walk distance according to american thoracic society (ATS) guidelines
Quality of life
时间窗: 5 weeks
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
次要结局
- tests of cognitive performance(5 weeks)
- Daily activity(5 week)
- hemodynamics by echocardiography(5 weeks)
- quality of life(5 weeks)
- arterial blood gas(5 weeks)
- operating hours of oxygen concentrator(5 weeks)
- mean nocturnal oxygen saturation(5 weeks)
- Quality of life(5 weeks)
- Venous blood(5 weeks)