NCT02793245

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2016

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

May 26, 2016

Last Update Submit

July 11, 2017

Conditions

Anatomy

Outcome Measures

Primary Outcomes (4)

  • Relationship between patients' age and the minimum diameter of the left main bronchus

    Age (years) and diameter (mm)

    1 year

  • Relationship between patients' gender and the minimum diameter of the left main bronchus

    Gender (male/female) and diameter (mm)

    1 year

  • Relationship between patients' height and the minimum diameter of the left main bronchus

    Height (cm) and diameter (mm)

    1 year

  • Relationship between patients' weight and the minimum diameter of the left main bronchus

    Weight (kg) and diameter (mm)

    1 year

Secondary Outcomes (3)

  • Relationship between patients functional test and the minimum diameter of the left main bronchus

    1 year

  • Relationship between patient characteristics and the measurement of lengths, diameters and cross-sectional areas of the trachea and of right main bronchus

    1 year

  • Validation of automatic measurement of tracheal and bronchial diameters

    1 year

Study Arms (1)

Studied population

EXPERIMENTAL

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: QuestionnaireOther: Simplified pulmonary function test

Interventions

QuestionnaireOTHER

Questionnaire on their main characteristics : age, gender, height, weight, smoking

Studied population
Simplified pulmonary function testOTHER
Studied population

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (13)

  • Jit H, Jit I. Dimensions & shape of the trachea in the neonates, children & adults in northwest India. Indian J Med Res. 2000 Jul;112:27-33.

    PMID: 11006658BACKGROUND

  • Chunder R, Nandi S, Guha R, Satyanarayana N. A morphometric study of human trachea and principal bronchi in different age groups in both sexes and its clinical implications. Nepal Med Coll J. 2010 Dec;12(4):207-14.

    PMID: 21744760BACKGROUND

  • Zahedi-Nejad N, Bakhshayesh-Karam M, Kahkoei S, Abbasi-Dezfoully A, Masjedi MR. Normal dimensions of trachea and two main bronchi in the Iranian population. Pol J Radiol. 2011 Oct;76(4):28-31.

    PMID: 22802851BACKGROUND

  • Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.

    PMID: 3674473BACKGROUND

  • Robinson CL, Muller NL, Essery C. Clinical significance and measurement of the length of the right main bronchus. Can J Surg. 1989 Jan;32(1):27-8.

    PMID: 2642720BACKGROUND

  • Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7. doi: 10.1016/s1053-0770(99)90003-4.

    PMID: 10527220BACKGROUND

  • Olivier P, Hayon-Sonsino D, Convard JP, Laloe PA, Fischler M. Measurement of left mainstem bronchus using multiplane CT reconstructions and relationship between patient characteristics or tracheal diameters and left bronchial diameters. Chest. 2006 Jul;130(1):101-7. doi: 10.1378/chest.130.1.101.

    PMID: 16840389BACKGROUND

  • Breatnach E, Abbott GC, Fraser RG. Dimensions of the normal human trachea. AJR Am J Roentgenol. 1984 May;142(5):903-6. doi: 10.2214/ajr.142.5.903.

    PMID: 6609569BACKGROUND

  • Kamel KS, Lau G, Stringer MD. In vivo and in vitro morphometry of the human trachea. Clin Anat. 2009 Jul;22(5):571-9. doi: 10.1002/ca.20815.

    PMID: 19544298BACKGROUND

  • Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.

    PMID: 9477054BACKGROUND

  • Mrudula C, Krishnaiah M. The study of bronchial tree. International Journal of Pharma and Bio Sciences 2011;2:B166-B172

    BACKGROUND

  • Otoch JP, Minamoto H, Perini M, Carneiro FO, de Almeida Artifon EL. Is there a correlation between right bronchus length and diameter with age? J Thorac Dis. 2013 Jun;5(3):306-9. doi: 10.3978/j.issn.2072-1439.2013.03.12.

    PMID: 23825764BACKGROUND

  • Kim JH, Park SH, Han SH, Nahm FS, Jung CK, Kim KM. The distance between the carina and the distal margin of the right upper lobe orifice measured by computerised tomography as a guide to right-sided double-lumen endobronchial tube use. Anaesthesia. 2013 Jul;68(7):700-5. doi: 10.1111/anae.12208. Epub 2013 May 8.

    PMID: 23656604BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Virginie Dumans-Nizard, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 8, 2016

Study Start

June 1, 2015

Primary Completion

November 21, 2016

Study Completion

November 21, 2016

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)