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Validation of Study in Respiratory Physiology and it Interactions (ValApPhI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881945
First Posted: June 20, 2013
Last Update Posted: June 20, 2013
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.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.

Condition Intervention
Life Experiences Respiratory Function Cardiac Function Other: Non-invasive physiological signal recording on healthy volunteer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Heart rate [ Time Frame: one measure within two weeks of inclusion ]
    Heart rate is calculated on electrocardiograph

  • end tidal CO2 [ Time Frame: one measure within two weeks of inclusion ]
    end tidal CO2 of each breath measured with an infrared CO2 analyzer

  • Non invasive arterial pressure [ Time Frame: one measure within two weeks of inclusion ]
  • Non invasive stroke volume [ Time Frame: one measure within two weeks of inclusion ]
    measured with impedance cardiography

  • Inspiratory and expiratory times [ Time Frame: one measure within two weeks of inclusion ]
    obtained for each breath with flow signal

  • Tidal volume [ Time Frame: one measure within two weeks of inclusion ]
    obtained for each breath with flow signal


Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physiological measurments Other: Non-invasive physiological signal recording on healthy volunteer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subject
  • between 18 and 60 years old

Exclusion Criteria:

  • patient
  • person protected by the law
  Contacts and Locations
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): NCT01881945


Contacts
Contact: BRIOT Raphael, MCU-PH 33 4 76 63 42 86 RBriot@chu-grenoble.fr

Locations
France
Laboratoire TIMC-IMAG Recruiting
La Tronche, France, 38700
Contact: Calabrese Pascale, PhD    33456520060    Pascale.Calabrese@imag.fr   
Principal Investigator: Briot Rapahel, MCU-PH         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: BRIOT Raphael, MCU-PH University Hospital, Grenoble
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01881945     History of Changes
Other Study ID Numbers: 2008-A00273-52
First Submitted: May 24, 2013
First Posted: June 20, 2013
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by University Hospital, Grenoble:
Swallowing
Hyperventilation