Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Exercise duration
研究概览
简要总结
Pulmonary arterial hypertension (PAH) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with PAH, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial. Based on the aforementioned, the purpose of this prospective, crossover clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with PAH, during steady state cardiopulmonary exercise testing (CPET)
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
- Single (Participant)
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
- •Group I PAH patients
- •Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month)
- •Presence of exercise-induced hypoxemia
排除标准
- •Major contraindications for CPET conduction
- •Not providing informed consent -
研究组 & 干预措施
PAH patients
Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
干预措施: Oxygen supplementation (Drug)
PAH patients (crossover)
Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask
干预措施: Sham O2 (medical air) (Drug)
结局指标
主要结局
Exercise duration
时间窗: through study completion, an average of a year
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
次要结局
- Dyspnea(through study completion, an average of a year)
- cerebral oxygenated hemoglobin(through study completion, an average of a year)
- Cardiac output(through study completion an average of a year)
- Fatigue(through study completion, an average of a year)
研究者
Afroditi Boutou
Consultant in Respiratory Medicine
George Papanicolaou Hospital
