CClinicalTrials.gg
Status unknownNCT02805413CeCiUpdated Jun 20, 2016

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

An interventional study of Détermination and comparison of blood pressure in BLOOD PRESSURE, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by University Hospital, Caen · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • BLOOD PRESSURE
03

In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Other
    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

Interventions

  • OtherDétermination 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.

06

What researchers measure

Primary outcomes

  1. Central arterial pressure

    Central arterial pressure evaluated by oscillographic upper arm measurements

    Time frame: baseline and when in gravity (same day)

Secondary outcomes

  1. Systolic time intervals

    Systolic time intervals evaluated in upright subjects regarding g-load.

    Time frame: baseline and when in gravity (same day)

  2. inert gas rebreathing

    Cardiac output by inert gas rebreathing

    Time frame: baseline and when in gravity (same day)

  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

    Cardiac output by different methods of pulse curve analysis will be evaluated for different g-loads.

    Time frame: baseline and when in gravity (same day)

07

Study locations

1 of 1 sites recruiting
  • Caen CHU
    Caen, 14000, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02805413
Lead sponsor
University Hospital, Caen
Collaborators
Novespace
Responsible party
Sponsor
First posted
Jun 20, 2016
Start date
Apr 2015
Primary completion
Apr 2018 (estimated)
Completion
Apr 2018 (estimated)
Last update
Jun 20, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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