Informations générales (source: ClinicalTrials.gov)

NCT02508818 Statut inconnu
(ORB)
Interventional
N/A
University Hospital, Caen (Voir sur ClinicalTrials)
juin 2011
29 juin 2024
There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research). Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Umr Ucbn/Inserm U1075 Comete - 14032 - Caen CEDEX - Basse-Normandie - France Pierre Denise, MD PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Healthy volunteers (men or women)

- Aged from 18 to 55

- Affiliated to a Social Security System

- Who accepted to take part in the study

- Who have given their written stated consent

- Who already participated in parabolic flights or performed a centrifuge run up to 4
G with head movements without occurrence of serious nausea or vomiting or
cardiovascular discomfort.

- 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.



- Person who took part in a previous biomedical research protocol, of which exclusion
period is not terminated

- Pregnant women

- Medication with beta blockers, ACE inhibitors, calcium channel blockers or
diuretics.