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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: anti-g maneuvers

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Caen CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: anti-g maneuvers; Before 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	during 15 parabola	baseline
cardiac output with ECG	during 15 parabola	baseline
blood pressure	during 15 parabola	baseline
oxygen uptake measured with a spirometer	during 15 parabola	baseline
carbon dioxide output measured with a spirometer	during 15 parabola	baseline
ventilation measured with a spirometer	during 15 parabola	baseline
breathing frequency measured with a spirometer	during 15 parabola	baseline
body core temperature measured with 2 temperature sensors - one on forehead and the other one chest	during 15 parabola	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Novespace
• Investigators: Principal Investigator: Pierre DP Denise, PhD, UMR 1075 UFR de Médecine Caen

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-A01258-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No