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

Healthy Volunteers Clinical Trial

— GasEx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850354
• Other study ID #: 2015-A01258-41
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2016
• Last updated: July 27, 2016
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: July 2016
• Source: University Hospital, Caen
• Contact: Pierre DP Denise, PhD
• Phone: 02.31.06.81.32
• Email: pierre.denise[@]unicaen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Caen CHU	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Novespace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	during 15 parabola	baseline	No
Primary	cardiac output with ECG	during 15 parabola	baseline	No
Primary	blood pressure	during 15 parabola	baseline	No
Primary	oxygen uptake measured with a spirometer	during 15 parabola	baseline	No
Primary	carbon dioxide output measured with a spirometer	during 15 parabola	baseline	No
Primary	ventilation measured with a spirometer	during 15 parabola	baseline	No
Primary	breathing frequency measured with a spirometer	during 15 parabola	baseline	No
Primary	body core temperature measured with 2 temperature sensors - one on forehead and the other one chest	during 15 parabola	baseline	No