NCT04076501已完成不适用
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Endurance Time (s) Endurance Time (s) Endurance Time (s)
研究概览
简要总结
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.
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
- 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
- •GUCH, stable medication for at least 4 weeks.
排除标准
- •instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
研究组 & 干预措施
Supplemental oxygen
Experimental
Supplemental oxygen will be applied via a mask during CPET
干预措施: Oxygen application (Procedure)
Sham room air
Sham Comparator
Room air will be applied similarly to oxygen
干预措施: Sham room air (Procedure)
结局指标
主要结局
Endurance Time (s) Endurance Time (s) Endurance Time (s)
时间窗: 1 day
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Work Rate (Watt)
时间窗: 1 day
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
次要结局
- muscle tissue oxygen(1 day)
- Respiratory Exchange ratio(1 day)
- Peak Oxygen uptake(1 day)
- Changes in arterial blood parameters(1 day)
- cerebral tissue oxygen(1 day)
研究者
研究点 (1)
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