Healthy VolunteersDYMCONCT02518880
Dynamics of Stroke Volume and Cardiac Output During Parabolic Flight, and Its Relationship to Intravascular Volume
A study testing Parabolic flight and plasma volume measurements in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Parabolic flight and plasma volume measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Feb 2012
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers (men or women),
- aged from 18 to 55,
- affiliated to a Social Security system,
- who accept to take part in the study,
- who have given their written stated consent,
- who already participated in parabolic flights (even in the same campaign)
- All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection
Who cannot join
- person who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system.
The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.
- Conditions
- Healthy Volunteers
- Being tested
- Parabolic flight, plasma volume measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
plasma volume measurementsOther
| Study group | Role | What they receive |
|---|---|---|
| Plasma volume measurements | Other | Not described Receives: Other: Parabolic flight; Other: plasma volume measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemoglobin concentration
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518880
- Sponsor's protocol ID
- 09-178
- Acronym
- DYMCO
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Stroke Volume and Cardiac Output During Parabolic Flight, and Its Relationship to Intravascular Volume
- ClinicalTrials.gov ID
- NCT02518880
- Acronym / sponsor ID
- DYMCO / 09-178
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 10 Aug 2015 (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.
To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system.
The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma volume measurements | Other | Other: Parabolic flight, Other: plasma volume measurements |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy volunteers (men or women),
- aged from 18 to 55,
- affiliated to a Social Security system,
- who accept to take part in the study,
- who have given their written stated consent,
Key exclusion criteria (2 listed)
- person who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- pregnant women
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 |
|---|---|---|
| Parabolic flight | Other | Plasma volume measurements |
| plasma volume measurements | Other | Plasma volume measurements |
Primary outcome
haemoglobin concentration
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight and plasma volume measurements 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 2 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: finished, as of the sponsor's last update on 10 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
haemoglobin concentration (time frame: baseline). 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 10 Aug 2015.