NCT01402752

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable healthy

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
2.3 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

July 25, 2011

Last Update Submit

June 17, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The time necessary to complete one measure of Qaw (minutes)

    Day 1

Study Arms (1)

All patients

EXPERIMENTAL

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

Biological: Blood flow to the tracheo-bronchial mucosa

Interventions

Blood flow to the tracheo-bronchial mucosaBIOLOGICAL

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

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Charles Le Merre, MD

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 18, 2026

Record last verified: 2017-06