Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness, a Pilot Crossover Trial at 6000 Meters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
- 主要终点
- Peripheral Oxygen Saturation (SpO2)
研究概览
简要总结
This pilot study aims to evaluate the efficacy of positive expiratory pressure (PEP) therapy at 10 cmH₂O in improving peripheral oxygen saturation (SpO₂) and mitigating symptoms of acute mountain sickness (AMS) in healthy individuals exposed to extreme altitude conditions.
Three male participants will be monitored during an ascent of Mount Aconcagua, Argentina, at elevations of 4,300 m, 5,560 m, and 6,000 m above sea level. The study involves three sequential phases of 10 minutes each: baseline breathing without PEP, breathing with PEP applied via a mechanical face mask, and post-PEP breathing.
Primary outcomes include changes in SpO₂ and Lake Louise Score (LLS) to assess AMS severity. Findings will provide preliminary data on the potential role of PEP as a non-pharmacological intervention in high-altitude medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without ongoing medical conditions
- •Over 18 years of age
- •Volunteers with the physical and technical skills necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina, and with previous experience at extreme altitudes
排除标准
- •Subjects with any ongoing medical conditions
- •Under 18 years of age
- •Subjects without previous mountaineering experience at extreme altitudes and without adequate physical and technical preparation necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina
结局指标
主要结局
Peripheral Oxygen Saturation (SpO2)
时间窗: During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl.
次要结局
- Lake Louise Score(During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl.)
研究者
Paolo Rodi
MD, MScMD, principal investigator
BiALP - Alpine, Disaster and Wilderness Medicine