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

Not Applicable
Conditions
Healthy Volunteers
Interventions
Other: anti-g maneuvers
Registration Number
NCT02850354
Lead Sponsor
University Hospital, Caen
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
18
Inclusion Criteria
  • 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.

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
anti-g maneuversanti-g maneuversBefore the first parabola, pulmonary function will be evaluated. Then during each weightlessness period the subject will be instructed either to stay at rest (control condition) or to perform anti-g maneuvers (4 times each): intermittent exhalation on exertion, lower limbs and abdomen muscular contraction, combined maneuver ('intermittent exhalation on exertion' + 'muscle contraction'). Before, the exhalation on exertion, the subject will close the airway after the mouthpiece by pushing on a button actuating a pneumatic valve. Each subject will be tested during 15 parabola where the anti-g maneuvers will be performed in randomized order. After the 15th parabola, pulmonary function will be again evaluated.
Primary Outcome Measures
NameTimeMethod
breathing frequency measured with a spirometerbaseline

during 15 parabola

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

during 15 parabola

ventilation measured with a spirometerbaseline

during 15 parabola

heart ratebaseline

during 15 parabola

cardiac output with ECGbaseline

during 15 parabola

blood pressurebaseline

during 15 parabola

oxygen uptake measured with a spirometerbaseline

during 15 parabola

carbon dioxide output measured with a spirometerbaseline

during 15 parabola

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Caen CHU

🇫🇷

Caen, France

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