3D Ballistocardiography in Microgravity

NCT02517112 | Unknown

• 1 other identifier: 11-126
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Cardiovascular parameters measurements

OTHER

Other: Parabolic flight; Other: Cardiovascular parameters measurements; Device: 3D-BCG sensor

Interventions

Parabolic flight OTHER

Cardiovascular parameters measurements

Cardiovascular parameters measurements OTHER

with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography

Cardiovascular parameters measurements

3D-BCG sensor DEVICE

Cardiovascular parameters measurements

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Difficulty to obtain a clear echocardiography.
• Pregnant women

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 6, 2015
• Study Start: December 1, 2011
• Primary Completion: October 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

FR (1)