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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01402752

Collaborator

(none)

Enrollment

Arm

3.9

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Blood flow to the tracheo-bronchial mucosa	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All patients All patients included in this study according to stated inclusion and exclusion criteria.	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.

Arm

Intervention/Treatment

Experimental: All patients

All patients included in this study according to stated inclusion and exclusion criteria.

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.

Outcome Measures

Primary Outcome Measures

The reproducibility of two measures of Qaw at a five minute interval [Five minutes]
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).

Secondary Outcome Measures

The time necessary to complete one measure of Qaw (minutes) [Day 1]
Qaw = blood flow measured in the tracheobronchial mucosa

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Charles Le Merre, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01402752

Other Study ID Numbers:

LOCAL/2011/CLM-02

First Posted:

Jul 26, 2011

Last Update Posted:

Jun 19, 2017

Last Verified:

Jun 1, 2017

Study Results

No Results Posted as of Jun 19, 2017