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

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Biological: Blood flow to the tracheo-bronchial mucosa

• Registration Number: NCT01402752
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2013-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood flow to the tracheo-bronchial mucosa	All patients included in this study according to stated inclusion and exclusion criteria.

Primary Outcome Measures

Name	Time	Method
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

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