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

June 17, 2013 updated by: University Hospital, Grenoble

Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • Recruiting
        • Laboratoire TIMC-IMAG
        • Contact:
        • Principal Investigator:
          • Briot Rapahel, MCU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subject
  • between 18 and 60 years old

Exclusion Criteria:

  • patient
  • person protected by the law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiological measurments
Other: Non-invasive physiological signal recording on healthy volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: one measure within two weeks of inclusion
Heart rate is calculated on electrocardiograph
one measure within two weeks of inclusion
end tidal CO2
Time Frame: one measure within two weeks of inclusion
end tidal CO2 of each breath measured with an infrared CO2 analyzer
one measure within two weeks of inclusion
Non invasive arterial pressure
Time Frame: one measure within two weeks of inclusion
one measure within two weeks of inclusion
Non invasive stroke volume
Time Frame: one measure within two weeks of inclusion
measured with impedance cardiography
one measure within two weeks of inclusion
Inspiratory and expiratory times
Time Frame: one measure within two weeks of inclusion
obtained for each breath with flow signal
one measure within two weeks of inclusion
Tidal volume
Time Frame: one measure within two weeks of inclusion
obtained for each breath with flow signal
one measure within two weeks of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: BRIOT Raphael, MCU-PH, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-A00273-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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