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: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Parabolic flight; Other: Cardiovascular parameters measurements; Device: 3D-BCG sensor

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

Contacts and Locations

Study Locations

• France
  • Basse-Normandie
    • Caen CEDEX, Basse-Normandie, France, 14032
      • Recruiting
      • Umr Ucbn/Inserm U1075 Comete

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardiovascular parameters measurements	Other: Parabolic flight; Other: Cardiovascular parameters measurements; with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography; Device: 3D-BCG sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol	baseline
stroke volume	evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol	baseline
ejection fraction	evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: volunteers
• Other Study ID Numbers: 11-126