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临床试验/NCT02850354
NCT02850354Unknown不适用

Gas Exchange and Cardiovascular Kinetics of Regulation - Effects of Short Term Changes in Gravity

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
18
试验地点
2
主要终点
breathing frequency measured with a spirometer

研究概览

简要总结

The regulation of the cardiovascular respiratory system after changing environmental conditions or changes in work rates are essential for cognitive as well as physical functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs cardiovascular function that may cause loss of consciousness. Some "anti-g" maneuvers, such as muscle contraction of the lower extremities and buttocks or intermittent exhalation on exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance to high +Gz.

Main objective of this experiment is to investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.

Cardiovascular and respiratory functions will be evaluated with the following parameters: heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide output, ventilation, breathing frequency, body core temperature.

Electromyography (EMG) will not be a judgment criteria but will be used to check the quality of 'muscle contraction' anti-g maneuver.

The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory tolerance to the push-pull effect, especially when they are combined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (men or women)
  • Aged from 20 to 65
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.
  • Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign.

排除标准

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Treated or non-treated arterial hypertension
  • Respiratory bacterial or viral infection
  • Pregnant women

结局指标

主要结局

breathing frequency measured with a spirometer

时间窗: baseline

during 15 parabola

body core temperature measured with 2 temperature sensors - one on forehead and the other one chest

时间窗: baseline

during 15 parabola

heart rate

时间窗: baseline

during 15 parabola

cardiac output with ECG

时间窗: baseline

during 15 parabola

blood pressure

时间窗: baseline

during 15 parabola

ventilation measured with a spirometer

时间窗: baseline

during 15 parabola

oxygen uptake measured with a spirometer

时间窗: baseline

during 15 parabola

carbon dioxide output measured with a spirometer

时间窗: baseline

during 15 parabola

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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