Validation of Study in Respiratory Physiology and it Interactions

Respiratory Function Clinical Trial

— ValApPhI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01881945
• Other study ID #: 2008-A00273-52
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2013
• Last updated: June 17, 2013
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Grenoble
• Contact: BRIOT Raphael, MCU-PH
• Phone: 33 4 76 63 42 86
• Email: RBriot[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy subject

• between 18 and 60 years old

Exclusion Criteria:

• patient

• person protected by the law

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Function
• Life Experiences
• Respiratory Function

Intervention

Other:
• Non-invasive physiological signal recording on healthy volunteer

Locations

Country	Name	City	State
France	Laboratoire TIMC-IMAG	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate is calculated on electrocardiograph	one measure within two weeks of inclusion	No
Primary	end tidal CO2	end tidal CO2 of each breath measured with an infrared CO2 analyzer	one measure within two weeks of inclusion	No
Primary	Non invasive arterial pressure		one measure within two weeks of inclusion	No
Primary	Non invasive stroke volume	measured with impedance cardiography	one measure within two weeks of inclusion	No
Primary	Inspiratory and expiratory times	obtained for each breath with flow signal	one measure within two weeks of inclusion	No
Primary	Tidal volume	obtained for each breath with flow signal	one measure within two weeks of inclusion	No