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

June 17, 2026 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The reproducibility of two measures of Qaw at a five minute interval
Time Frame: 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).
Five minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time necessary to complete one measure of Qaw (minutes)
Time Frame: Day 1
Qaw = blood flow measured in the tracheobronchial mucosa
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

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

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

November 1, 2013

Primary Completion (Estimated)

March 1, 2014

Study Completion (Estimated)

March 1, 2014

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimated)

July 26, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • LOCAL/2011/CLM-02

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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