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临床试验/NCT02508818
NCT02508818Unknown不适用

Cardiovascular Response to Orthostatic Fractional 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: 2011年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
18
试验地点
2
主要终点
systolic finger blood pressure

研究概览

简要总结

There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (men or women)
  • Aged from 18 to 55
  • Affiliated to a Social Security System
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • Who already participated in parabolic flights or performed a centrifuge run up to 4 G with head movements without occurrence of serious nausea or vomiting or cardiovascular discomfort.
  • 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.

排除标准

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Pregnant women
  • Medication with beta blockers, ACE inhibitors, calcium channel blockers or diuretics.

研究组 & 干预措施

Cardiovascular measurements

Other

干预措施: Cardiovascular measurements (Other)

Cardiovascular measurements

Other

干预措施: Parabolic flight (Other)

结局指标

主要结局

systolic finger blood pressure

时间窗: baseline

Heart rate

时间窗: baseline

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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