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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02850354
Acronym
GasEx
Enrollment
18
Registered
2016-08-01
Start date
2015-10-31
Completion date
2018-10-31
Last updated
2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

OTHERanti-g maneuvers

investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.

Sponsors

Novespace
CollaboratorINDUSTRY
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
heart ratebaselineduring 15 parabola
cardiac output with ECGbaselineduring 15 parabola
blood pressurebaselineduring 15 parabola
oxygen uptake measured with a spirometerbaselineduring 15 parabola
carbon dioxide output measured with a spirometerbaselineduring 15 parabola
ventilation measured with a spirometerbaselineduring 15 parabola
breathing frequency measured with a spirometerbaselineduring 15 parabola
body core temperature measured with 2 temperature sensors - one on forehead and the other one chestbaselineduring 15 parabola

Countries

France

Contacts

Primary ContactPierre DP Denise, PhD
pierre.denise@unicaen.fr02.31.06.81.32
Backup ContactCathy GC Gaillard
gaillard-c@chu-caen.fr02 31 06 53 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026