CO2 Supplement for Prophylaxis and Treatment of Acute Mountain Sickness Using Novel Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence rate of acute mountain sickness (AMS)
研究概览
简要总结
It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. It has also been well documented that exercise capacity was impaired at high altitude. Oxygen inhalation is the most effective treatment method, but it is impractical for outdoor activities because of the large volume required. There are some drugs such as acetazolamide, and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use. It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA. There is no available device which can accurately supply constant CO2 and is functionally free of dead space. We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS.
详细描述
Objective
To determine whether, after rapid ascent to high altitude the device could reduce the incidence and severity of AMS as defined by AMS scores, improve sleep quality and reduce central sleep apnea events.
Methods: A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude (>1000m) a year before the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep. Blood gases will be measured 30 minutes after inhalation of air or CO2. SaO2, heart rate, and respiratory rate will be recorded every two hours. AMS (Lake Louise Acute Mountain Sickness Score) will be recorded before and after sleep. PSG including diaphragm EMG would be recorded under CO2 or air. Exercise time, ventilation heart rate, respiratory rate, and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or ambient air.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI less than 25kg/m2
- •normal lung function.
- •Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
排除标准
- •moderate or severe OSA based on PSG at sea level (AHI> 15 events/hr).
- •visited to an altitude >2500 m in the preceding year.
- •Currently using medicines for diabetes, hypertension et al.
研究组 & 干预措施
Breathing with CO2 during daytime and night at high altitude
Subjects will sleep and perform exercise tests under inhalation of low concentration of CO2 supplied by a novel device at high altitude.
干预措施: Breathing with CO2 during daytime and night at high altitude (Device)
Breathing with air during daytime and night at high altitude
Subjects will sleep and perform exercise tests under inhalation of air at high altitude.
干预措施: Sleep and doing exercise test under inhalation of air (Device)
结局指标
主要结局
Incidence rate of acute mountain sickness (AMS)
时间窗: 72 hours
Incidence rate of AMS based on Louis's scores under inhalation of CO2 and ambient air. The maximum score is 12 points, and a score greater than 3 indicates the presence of AMS.
The severity of AMS
时间窗: 72 hours
The severity of AMS based on Louis's scores under inhalation of CO2 and ambient air. A score of 3-5 indicates mild AMS, a score of 6-9 indicates moderate AMS and a score of 10-12 indicates severe AMS.
次要结局
- Workload in the incremental ergometer test(72 hours)
- Sleep quality based on PSG(72 hours)
- Exercise duration in the incremental ergometer test(72 hours)
- Central sleep apnea index based on PSG(72 hours)
研究者
Yuan-Ming Luo
Professor
State Key Laboratory of Respiratory Disease