Patient Characteristics and Tracheobronchial Anatomy (Scan-Bronchi)

July 11, 2017 updated by: Hopital Foch

Influence of Patient Characteristics on the Tracheobronchial Anatomy Evaluated by a CT Examination

The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge of the tracheobronchial anatomy in order to establish the best choice for the patient. The literature is limited regarding major bronchi dimensions. In addition, the measurement method is not always adequate or properly described and some publications have evaluated only the left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has been little used.

The project is to conduct a prospective study to compare patient characteristics (age, height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if available), and dimensions of the trachea and of the main bronchi from CT scans with 3D reconstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital Foch

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged at least 18 years
  • undergoing a CT scan

Exclusion Criteria:

  • hospitalized patients,
  • people benefiting from a legal protection.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Studied population
Patients will be questioned about their main characteristics (age, gender, height, weight, smoking), they will also perform a simplified a pulmonary function test (if possible).
Other: Questionnaire
Questionnaire on their main characteristics : age, gender, height, weight, smoking
Other: Simplified pulmonary function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between patients' age and the minimum diameter of the left main bronchus
Time Frame: 1 year
Age (years) and diameter (mm)
1 year
Relationship between patients' gender and the minimum diameter of the left main bronchus
Time Frame: 1 year
Gender (male/female) and diameter (mm)
1 year
Relationship between patients' height and the minimum diameter of the left main bronchus
Time Frame: 1 year
Height (cm) and diameter (mm)
1 year
Relationship between patients' weight and the minimum diameter of the left main bronchus
Time Frame: 1 year
Weight (kg) and diameter (mm)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between patients functional test and the minimum diameter of the left main bronchus
Time Frame: 1 year
Forced expiratory volume (% of reference value) and diameter (mm)
1 year
Relationship between patient characteristics and the measurement of lengths, diameters and cross-sectional areas of the trachea and of right main bronchus
Time Frame: 1 year
1 year
Validation of automatic measurement of tracheal and bronchial diameters
Time Frame: 1 year
Comparison between manual and automatic measurement using the software "Thoracic VCAR" of General Electric
1 year

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Virginie Dumans-Nizard, MD, Hôpital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Actual)

November 21, 2016

Study Completion (Actual)

November 21, 2016

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/25
  • 2014-A00826-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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