- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517112
3D Ballistocardiography in Microgravity (B3D)
3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS.
The aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, France, 14032
- Recruiting
- Umr Ucbn/Inserm U1075 Comete
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers (men or women)
- Aged from 18 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
- Whose 4 chamber view of the heart during a breath hold is easy to get during a routine cardiac echocardiography (M-Mode - apical view).
- 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.
Exclusion Criteria:
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Difficulty to obtain a clear echocardiography.
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cardiovascular parameters measurements
|
with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: baseline
|
evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol
|
baseline
|
stroke volume
Time Frame: baseline
|
evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol
|
baseline
|
ejection fraction
Time Frame: baseline
|
evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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