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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01881945
First received: May 24, 2013
Last updated: June 17, 2013
Last verified: June 2013
  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: 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 ] [ Designated as safety issue: No ]
    Heart rate is calculated on electrocardiograph

  • end tidal CO2 [ Time Frame: one measure within two weeks of inclusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Non invasive stroke volume [ Time Frame: one measure within two weeks of inclusion ] [ Designated as safety issue: No ]
    measured with impedance cardiography

  • Inspiratory and expiratory times [ Time Frame: one measure within two weeks of inclusion ] [ Designated as safety issue: No ]
    obtained for each breath with flow signal

  • Tidal volume [ Time Frame: one measure within two weeks of inclusion ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01881945     History of Changes
Other Study ID Numbers: 2008-A00273-52
Study First Received: May 24, 2013
Last Updated: June 17, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
Swallowing
Hyperventilation

ClinicalTrials.gov processed this record on August 21, 2014