Healthy VolunteersGasExNCT02850354
Gas Exchange and Cardiovascular Kinetics of Regulation - Effects of Short Term Changes in Gravity
A study testing anti-g maneuvers in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- anti-g maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- anti-g maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-g maneuversOther
investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.
| Study group | Role | What they receive |
|---|---|---|
| anti-g maneuvers | Experimental | 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. Receives: Other: anti-g maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
during 15 parabola
Measured: baseline
cardiac output with ECG
during 15 parabola
Measured: baseline
blood pressure
during 15 parabola
Measured: baseline
oxygen uptake measured with a spirometer
during 15 parabola
Measured: baseline
carbon dioxide output measured with a spirometer
during 15 parabola
Measured: baseline
ventilation measured with a spirometer
during 15 parabola
Measured: baseline
breathing frequency measured with a spirometer
during 15 parabola
Measured: baseline
body core temperature measured with 2 temperature sensors - one on forehead and the other one chest
during 15 parabola
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Novespace
- Responsible party
- Sponsor
- Investigators
- Pierre DP Denise, PhD, Principal investigator, UMR 1075 UFR de Médecine Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850354
- Sponsor's protocol ID
- 2015-A01258-41
- Acronym
- GasEx
- Status last verified
- Jul 2016
- First submitted
- 21 Apr 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Exchange and Cardiovascular Kinetics of Regulation - Effects of Short Term Changes in Gravity
- ClinicalTrials.gov ID
- NCT02850354
- Acronym / sponsor ID
- GasEx / 2015-A01258-41
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Novespace
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-g maneuvers | Experimental | Other: anti-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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-g maneuversinvestigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect. | Other | anti-g maneuvers |
Primary outcome
heart rate
Time frame: baseline
during 15 parabola
cardiac output with ECG
Time frame: baseline
during 15 parabola
blood pressure
Time frame: baseline
during 15 parabola
oxygen uptake measured with a spirometer
Time frame: baseline
during 15 parabola
carbon dioxide output measured with a spirometer
Time frame: baseline
during 15 parabola
ventilation measured with a spirometer
Time frame: baseline
during 15 parabola
breathing frequency measured with a spirometer
Time frame: baseline
during 15 parabola
body core temperature measured with 2 temperature sensors - one on forehead and the other one chest
Time frame: baseline
during 15 parabola
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre DP Denise, PhD principal investigator
UMR 1075 UFR de Médecine Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-g maneuvers in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre DP Denise, PhD (02.31.06.81.32 ext. +33, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.