Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique (CeCi)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02805413|
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Main objective of the experiment is threefold: 1) to technically test a device for central blood pressure estimation for its applicability in a spaceflight-related environment and on the International Space Station. 2) Furthermore the objective is to compare central blood pressure estimates based on arterial pressure readings of different peripheral arteries. For central blood pressure estimation mathematical transfer functions as described by Karamanoglu and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously apply phonocardiography together with ECG and carotid plethysmography to determine cardiac systolic time intervals in parabolic flight during gravity transitions.
Secondary objective of the experiment is to simultaneously measure key variables of the central circulation during gravity transitions to expand the understanding of cardiovascular regulation in weightlessness. Furthermore spirometric measurements shall be performed during a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is central for cardiovascular regulation.
Our main hypothesis is that there is no difference between different methods of central arteria pressure determination.
Concerning our secondary objective, this experiment is designed as an observational study. Thus no clear hypothesis was generated but the measured cardiovascular and respiratory variables will be analysed regarding differences correlated to gravity.
|Condition or disease||Intervention/treatment||Phase|
|BLOOD PRESSURE||Other: Détermination and comparison of blood pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
DETERMINATION OF BLOOD PRESSURE
determination and comparison of blood pressure by/with :
Other: Détermination and comparison of blood pressure
Rebreathings will be performed every parabola (2, 4, 6, 8, 10…). Ultrasound measurements will be performed during the remaining parabolas (1, 3, 5, 7, 9…). The procedure consists of a fixed breathing frequency of 20 breaths per minute and an exact triggered start point for the measurements. . Central blood pressure measurements, finger blood pressure measurements, impedance cardiography, carotid plethysmography and phonocardiography will be performed continuously during the flights. The breaks between parabolas 10 and 11 and 20 and 21 will be used to change subjects, which takes approximately 5 minutes.
- Central arterial pressure [ Time Frame: baseline and when in gravity (same day) ]Central arterial pressure evaluated by oscillographic upper arm measurements
- Systolic time intervals [ Time Frame: baseline and when in gravity (same day) ]Systolic time intervals evaluated in upright subjects regarding g-load.
- inert gas rebreathing [ Time Frame: baseline and when in gravity (same day) ]Cardiac output by inert gas rebreathing
- heart rate [ Time Frame: baseline and when in gravity (same day) ]
- peripheral blood pressure [ Time Frame: baseline and when in gravity (same day) ]
- different methods of pulse curve analysis [ Time Frame: baseline and when in gravity (same day) ]Cardiac output by different methods of pulse curve analysis will be evaluated for different g-loads.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805413
|Contact: Pierre DP Denise, PhD||02.31.06.81.32 ext +firstname.lastname@example.org|
|Contact: Cathy GC Gaillard||02 31 06 53 49 ext +email@example.com|
|Caen, France, 14000|
|Principal Investigator:||Pierre DP Denise, PhD||CHU Caen|