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Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique (CeCi)

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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
Sponsor:
Collaborator:
Novespace
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
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

Arm Intervention/treatment
DETERMINATION OF BLOOD PRESSURE

determination and comparison of blood pressure by/with :

  • Pulse Curve Analysis
  • Inert gas re-breathing
  • Central blood pressure device
  • Vascular ultrasound device
  • Thoracic Impedance (ICG) - Electrocardiography (ECG) - Phonocardiography (Phono) - Carotid plethysmography (Pneumo)
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.




Primary Outcome Measures :
  1. Central arterial pressure [ Time Frame: baseline and when in gravity (same day) ]
    Central arterial pressure evaluated by oscillographic upper arm measurements


Secondary Outcome Measures :
  1. Systolic time intervals [ Time Frame: baseline and when in gravity (same day) ]
    Systolic time intervals evaluated in upright subjects regarding g-load.

  2. inert gas rebreathing [ Time Frame: baseline and when in gravity (same day) ]
    Cardiac output by inert gas rebreathing

  3. heart rate [ Time Frame: baseline and when in gravity (same day) ]
  4. peripheral blood pressure [ Time Frame: baseline and when in gravity (same day) ]
  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • 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.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Exclusion Criteria:

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Treated or non-treated arterial hypertension
  • Pregnant women

Information from the National Library of Medicine

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


Contacts
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Contact: Pierre DP Denise, PhD 02.31.06.81.32 ext +33 pierre.denise@unicaen.fr
Contact: Cathy GC Gaillard 02 31 06 53 49 ext +33 gaillard-c@chu-caen.fr

Locations
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France
Caen CHU Recruiting
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Novespace
Investigators
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Principal Investigator: Pierre DP Denise, PhD CHU Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02805413    
Other Study ID Numbers: 2015-A00264-45
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No