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临床试验/NCT02805413
NCT02805413Unknown不适用

Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年4月1日最近更新:
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
1
主要终点
Central arterial pressure

研究概览

简要总结

Main objective of the experiment is threefold: 1) to technically test a device for central blood pressure estimation for its applicability in a spaceflight-related environment and on the International Space Station. 2) Furthermore the objective is to compare central blood pressure estimates based on arterial pressure readings of different peripheral arteries. For central blood pressure estimation mathematical transfer functions as described by Karamanoglu and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously apply phonocardiography together with ECG and carotid plethysmography to determine cardiac systolic time intervals in parabolic flight during gravity transitions.

Secondary objective of the experiment is to simultaneously measure key variables of the central circulation during gravity transitions to expand the understanding of cardiovascular regulation in weightlessness. Furthermore spirometric measurements shall be performed during a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is central for cardiovascular regulation.

Our main hypothesis is that there is no difference between different methods of central arteria pressure determination.

Concerning our secondary objective, this experiment is designed as an observational study. Thus no clear hypothesis was generated but the measured cardiovascular and respiratory variables will be analysed regarding differences correlated to gravity.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers (men or women)
  • •Aged from 18 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
  • •Pregnant women

研究组 & 干预措施

DETERMINATION OF BLOOD PRESSURE

Other

determination and comparison of blood pressure by/with :

  • Pulse Curve Analysis
  • Inert gas re-breathing
  • Central blood pressure device
  • Vascular ultrasound device
  • Thoracic Impedance (ICG) - Electrocardiography (ECG) - Phonocardiography (Phono) - Carotid plethysmography (Pneumo)

干预措施: Détermination and comparison of blood pressure (Other)

结局指标

主要结局

Central arterial pressure

时间窗: baseline and when in gravity (same day)

Central arterial pressure evaluated by oscillographic upper arm measurements

次要结局

  • Systolic time intervals(baseline and when in gravity (same day))
  • inert gas rebreathing(baseline and when in gravity (same day))
  • heart rate(baseline and when in gravity (same day))
  • peripheral blood pressure(baseline and when in gravity (same day))
  • different methods of pulse curve analysis(baseline and when in gravity (same day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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