ValApPhI: Validation of Study in Respiratory Physiology and it Interactions
Sponsor
University Hospital, Grenoble (Other)
Overall Status
Unknown status
CT.gov ID
NCT01881945
Collaborator
(none)
50
1
1
60
0.8
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
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.
Study Start Date
:
Sep 1, 2008
Anticipated Primary Completion Date
:
Sep 1, 2013
Anticipated Study Completion Date
:
Sep 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Physiological measurments
|
Other: Non-invasive physiological signal recording on healthy volunteer
|
Outcome Measures
Primary Outcome Measures
- Heart rate [one measure within two weeks of inclusion]
Heart rate is calculated on electrocardiograph
- end tidal CO2 [one measure within two weeks of inclusion]
end tidal CO2 of each breath measured with an infrared CO2 analyzer
- Non invasive arterial pressure [one measure within two weeks of inclusion]
- Non invasive stroke volume [one measure within two weeks of inclusion]
measured with impedance cardiography
- Inspiratory and expiratory times [one measure within two weeks of inclusion]
obtained for each breath with flow signal
- Tidal volume [one measure within two weeks of inclusion]
obtained for each breath with flow signal
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
healthy subject
-
between 18 and 60 years old
Exclusion Criteria:
-
patient
-
person protected by the law
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratoire TIMC-IMAG | La Tronche | France | 38700 |
Sponsors and Collaborators
- University Hospital, Grenoble
Investigators
- Principal Investigator: BRIOT Raphael, MCU-PH, University Hospital, Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01881945
Other Study ID Numbers:
- 2008-A00273-52
First Posted:
Jun 20, 2013
Last Update Posted:
Jun 20, 2013
Last Verified:
Jun 1, 2013