NCT05089487已完成不适用
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
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
- 28
- 试验地点
- 1
- 主要终点
- Proportion of patients free of severe hypoxemia
研究概览
简要总结
The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary 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
- Screening
- 盲法
- None
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
- •Informed consent as documented by signature (Appendix Informed Consent Form)
- •PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
排除标准
- •resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- •exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- •inability to follow the procedures of the study
- •other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
研究组 & 干预措施
High altitude 2500 m above sea level
Experimental
干预措施: Nocturnal rest (sleep study) (Procedure)
Low altitude 470 m above sea level
Active Comparator
干预措施: Nocturnal rest (sleep study) (Procedure)
结局指标
主要结局
Proportion of patients free of severe hypoxemia
时间窗: 30 hours
Proportion of patients free of severe hypoxemia (defined as oxygenation (SpO2)\<80% for \>30 min) without oxygen therapy during nocturnal rest at 2500 m vs. 490 m
次要结局
- Oxygen desaturation index(30 hours)
- Cerebral tissue deoxygenation(30 hours)
- Cerebral tissue oxygen saturation during sleep without oxygen(30 hours)
- Time spent awake during the night(30 hours)
- Nocturnal oxygenation(30 hours)
- Periodic breathing(30 hours)
- Nocturnal transcutaneous carbon dioxide tension(30 hours)
- Cerebral tissue oxygen saturation awake(30 hours)
- Cerebral tissue oxygen saturation during sleep with oxygen(30 hours)
- Visual Analogue Scale(30 hours)
- Cerebral oxygen desaturation index without oxygen(30 hours)
- Cerebral tissue oxygen saturation between different sleep stages(30 hours)
- Cerebral oxygen desaturation index with oxygen(30 hours)
研究者
研究点 (1)
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