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

NCT02805413 | Unknown

• 1 other identifier: 2015-A00264-45
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

BLOOD PRESSURE

Outcome Measures

Primary Outcomes (1)

• Central arterial pressure

  Central arterial pressure evaluated by oscillographic upper arm measurements

  baseline and when in gravity (same day)

Secondary Outcomes (5)

• Systolic time intervals

  baseline and when in gravity (same day)

• inert gas rebreathing

  baseline and when in gravity (same day)

• heart rate

  baseline and when in gravity (same day)

• peripheral blood pressure

  baseline and when in gravity (same day)

• different methods of pulse curve analysis

  baseline and when in gravity (same day)

Study Arms (1)

DETERMINATION OF BLOOD PRESSURE

OTHER

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

Détermination and comparison of blood pressure OTHER

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.

DETERMINATION OF BLOOD PRESSURE

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
• 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

You may not qualify if:

• Treated or non-treated arterial hypertension
• Pregnant women

Sponsors & Collaborators

• University Hospital, Caen: lead
• Novespace: collaborator

Study Sites (1)

Caen CHU

Caen, 14000, France

RECRUITING

Study Officials

• Pierre DP Denise, PhD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

02.31.06.81.32; pierre.denise@unicaen.fr

Cathy GC Gaillard

CONTACT

02 31 06 53 49; gaillard-c@chu-caen.fr

Study Design

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

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: June 20, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)