Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia
研究概览
简要总结
Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel.
Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically indicated right heart catheterisation
- •diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension
排除标准
- •hemodynamically unstable
- •partial pressure of Oxygen < 7.3kPa
- •no informed consent
- •pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015
结局指标
主要结局
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia
时间窗: Day 1
次要结局
- change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia(Day 1)
- change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia(Day 1)
- change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia(Day 1)
- change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia(Day 1)