跳至主要内容
临床试验/NCT03683082
NCT03683082Unknown不适用

Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients

George Papanicolaou Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月5日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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)

Sham Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afroditi Boutou

Consultant in Respiratory Medicine

George Papanicolaou Hospital

研究点 (1)

Loading locations...

相似试验

Oxygen Treatment and Pulmonary Arterial Hypertension | 临床试验