System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility

Healthy Clinical Trial

Official title:

System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01402752
• Other study ID #: LOCAL/2011/CLM-02
• Status: Withdrawn
• Phase: N/A
• First received: July 25, 2011
• Last updated: June 16, 2017
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the reproducibility of a method of measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a tracer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

Exclusion Criteria:

• The patient is under judicial protection, under tutorship or curatorship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• Patient is pregnant

• Patient is breast feeding

• The patient is a smoker

• The patient has, or has a history of, chronic respiratory insufficiency

• The patient has a contra-indication for a treatment necessary in this study

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Blood flow to the tracheo-bronchial mucosa
Measurement of blood flow to the tracheo-bronchial mucosa via differential absorption of diluted dimethyl ether tracer gas.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reproducibility of two measures of Qaw at a five minute interval	Qaw is the blood flow measured in the tracheobronchial mucosa. Qaw = VDME/(FDME*alpha*10s) where VDME is the volume of dimethyl-ether exhaled (ml), FDME is the mean concentration of dimethyl-ether (%), alpha is the Bunsen coefficient for the dissolution of dimethyl ether in tissues and blood at 37°C (i.e. 9ml/ml).	Five minutes
Secondary	The time necessary to complete one measure of Qaw (minutes)	Qaw = blood flow measured in the tracheobronchial mucosa	Day 1