Patient Characteristics and Tracheobronchial Anatomy

Anatomy Clinical Trial

— Scan-Bronchi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793245
• Other study ID #: 2014/25
• Secondary ID: 2014-A00826-41
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: July 11, 2017
• Start date: June 2015
• Est. completion date: November 21, 2016

Study information

• Verified date: July 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 21, 2016
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged at least 18 years

• undergoing a CT scan

Exclusion Criteria:

• hospitalized patients,

• people benefiting from a legal protection.

Related Conditions & MeSH terms

• Anatomy

Intervention

Other:
• Questionnaire
Questionnaire on their main characteristics : age, gender, height, weight, smoking
• Simplified pulmonary function test

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View Citation

Breatnach E, Abbott GC, Fraser RG. Dimensions of the normal human trachea. AJR Am J Roentgenol. 1984 May;142(5):903-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Olivier P, Hayon-Sonsino D, Convard JP, Laloë 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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between patients' age and the minimum diameter of the left main bronchus	Age (years) and diameter (mm)	1 year
Primary	Relationship between patients' gender and the minimum diameter of the left main bronchus	Gender (male/female) and diameter (mm)	1 year
Primary	Relationship between patients' height and the minimum diameter of the left main bronchus	Height (cm) and diameter (mm)	1 year
Primary	Relationship between patients' weight and the minimum diameter of the left main bronchus	Weight (kg) and diameter (mm)	1 year
Secondary	Relationship between patients functional test and the minimum diameter of the left main bronchus	Forced expiratory volume (% of reference value) and diameter (mm)	1 year
Secondary	Relationship between patient characteristics and the measurement of lengths, diameters and cross-sectional areas of the trachea and of right main bronchus		1 year
Secondary	Validation of automatic measurement of tracheal and bronchial diameters	Comparison between manual and automatic measurement using the software "Thoracic VCAR" of General Electric	1 year