Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Digit-Symbol Substitution Task - DSST
研究概览
简要总结
The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level).
Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation.
On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure.
During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages:
- a basal cognitive test battery
- blind ascent in the hypobaric chamber to simulated altitude
- cognitive test battery
- 5 minutes of recorded chest compressions on dummies
- cognitive test battery
- blind descent in the hypobaric chamber.
During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device.
Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age 18-60 yr-old
- •ASA class I
- •Signed informed consent
排除标准
- •Age <18 or >60 yr-old
- •ASA class > I
- •Informed consent not signed
结局指标
主要结局
Digit-Symbol Substitution Task - DSST
时间窗: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in working memory at altitude using a computer-based test (DSST)
Psychomotor Vigilance Test - PVT
时间窗: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in reaction time using a computer-based test (PVT)
Balloon Analog Risk Test - BART
时间窗: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in risk-taking behavior at altitude using a computer-based test (BART)
次要结局
- Balloon Analog Risk Test - BART(Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude))
- Digit-Symbol Substitution Task - DSST(Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude))
- Proportion of correct chest compressions regarding depth, pressure point and pressure release(Changes in 5 minute chest compressions)
- Psychomotor Vigilance Test - PVT(Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude))
- Reactive oxygen species - ROS(Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour))
- Total antioxidant capacity - TAC(Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour))
研究者
Giacomo Strapazzon, MD PhD
Principal Investigator
Institute of Mountain Emergency Medicine