- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366455
New Measures for Tracheobronchial Anatomy (ATB)
April 8, 2020 updated by: Jean Bussières, Laval University
Knowing the Right Upper Lobe Anatomy Allows for the Efficient Use of the Right-sided Double Lumen Endobronchial Tube
The right-sided double lumen endobronchial tube (R-DLT) is seldom.
The principal cause of reticence for using the R-DLT are the difficult positioning of its lateral orifice in front of the origin of the right upper lobe (RUL) and the variability of the length of the right main stem bronchus (RMSB).
Both the angle between the right upper lobe (RUL) bronchus origin and the RMSB and the length of the RMSB can be measured with high resolution CT-scan.
These measures can be useful in clinical practice as they help to determine when a R-DLT should not be used or used with caution when facing a large variation of the angle of the RUL or a proximal implantation of a RUL bronchus .
Study Overview
Status
Completed
Detailed Description
Since the introduction in the early '80s of the disposable double-lumen endobronchial tube (DLT), combined with the use of fiberoptic bronchoscopy (FOB) to confirm its positioning, some controversies have aroused; the main concern being the use of the right-sided double-lumen endobronchial tube (R-DLT).
Alongside this persistent controversy, the anatomy of the right tracheo-bronchial tree seems to be the principal cause of reticence for using the R-DLT.
Compared to the left main stem bronchus, this anatomy is relatively complex and can be divided in two issues: 1) the variable length of the right main-stem bronchus (RMSB) and consequently, the variable level of insertion of the right upper lobe (RUL) bronchus on the lateral part of the RMSB and 2) the alignment of the lateral orifice of the R-DLT in regard of the RUL bronchus origin.
A as part of an extensive study of the tracheo-bronchial tree anatomy with high resolution CT-scan, we had the opportunity to measure differently the length of the main stem right bronchus and the angulation between the RUL bronchus origin and the lateral aspect of the right side main stem bronchus.
Study Type
Observational
Enrollment (Actual)
106
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
35 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Evaluation of radiological consecutives thoracic CT-Scan reconstruction in a tertiary university hearth and lung institute.
Patients had CT- scan for diagnosis or follow-up purposes
Description
Inclusion Criteria:
- Aged 35 to 85 years old
Exclusion Criteria:
- Unavailable weight and height
- Tracheobronchial tree pathologies (e.g. : tracheomalacia, tracheobronchomegaly, endobronchial lesions, bronchiectasis, etc.)
- Mediastinal pathologies inducing an extrinsic compression of the tracheobronchial tree.
- Pulmonary pathologies inducing a deformation of the tracheobronchial tree (e.g.: retraction, important atelectasis, pulmonary fibrosis, chronic tuberculosis, etc.)
- Patients that have had a treatment or surgery inducing a deformation of the tracheobronchial tree (e.g.: lobectomy, pneumonectomy, radiotherapy)
- An important musculoskeletal deformity at the thoracic level
- Low-quality CT scan exams (e.g.: significant kinetic artifacts where measurements should be taken
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Thoracic CT-Scan
Measurement of the length of the right main stem bronchus and of the right upper lobe bronchus antero-posterior angulation on consecutive thoracic CT-Scan reconstruction
|
Measurement of the length of the right main stem bronchus on CT-Scan
Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of the length of the right mainstem bronchus
Time Frame: 1 day
|
1 day
|
|
Measure of the right upper lobe bronchus antero-posterior angulation
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean S. Bussières, M.D., Laval University
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
- Slinger P. The clinical use of right-sided double-lumen tubes. Can J Anaesth. 2010 Apr;57(4):293-300. doi: 10.1007/s12630-009-9262-z. No abstract available. English, French.
- McKenna MJ, Wilson RS, Botelho RJ. Right upper lobe obstruction with right-sided double-lumen endobronchial tubes: a comparison of two tube types. J Cardiothorac Anesth. 1988 Dec;2(6):734-40. doi: 10.1016/0888-6296(88)90096-8.
- Bussieres JS, Lacasse Y, Cote D, Beauvais M, St-Onge S, Lemieux J, Soucy J. Modified right-sided Broncho-Cath double lumen tube improves endobronchial positioning: a randomized study. Can J Anaesth. 2007 Apr;54(4):276-82. doi: 10.1007/BF03022772.
- Hurford WE, Alfille PH. A quality improvement study of the placement and complications of double-lumen endobronchial tubes. J Cardiothorac Vasc Anesth. 1993 Oct;7(5):517-20. doi: 10.1016/1053-0770(93)90305-5.
- 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.
- 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.
- 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.
- Benumof JL. Improving the design and function of double-lumen tubes. J Cardiothorac Anesth. 1988 Dec;2(6):729-33. doi: 10.1016/0888-6296(88)90095-6. No abstract available.
- Benumof JL. The position of a double-lumen tube should be routinely determined by fiberoptic bronchoscopy. J Cardiothorac Vasc Anesth. 1993 Oct;7(5):513-4. doi: 10.1016/1053-0770(93)90303-3. No abstract available.
- Campos JH, Massa FC, Kernstine KH. The incidence of right upper-lobe collapse when comparing a right-sided double-lumen tube versus a modified left double-lumen tube for left-sided thoracic surgery. Anesth Analg. 2000 Mar;90(3):535-40. doi: 10.1097/00000539-200003000-00007.
- Ehrenfeld JM, Walsh JL, Sandberg WS. Right- and left-sided Mallinckrodt double-lumen tubes have identical clinical performance. Anesth Analg. 2008 Jun;106(6):1847-52. doi: 10.1213/ane.0b013e31816f24d5.
- Ehrenfeld JM, Mulvoy W, Sandberg WS. Performance comparison of right- and left-sided double-lumen tubes among infrequent users. J Cardiothorac Vasc Anesth. 2010 Aug;24(4):598-601. doi: 10.1053/j.jvca.2009.09.007. Epub 2009 Nov 25.
- Ikeno S, Mitsuhata H, Saito K, Hirabayashi Y, Akazawa S, Kasuda H, Shimizu R. Airway management for patients with a tracheal bronchus. Br J Anaesth. 1996 Apr;76(4):573-5. doi: 10.1093/bja/76.4.573.
- Hagihira S, Takashina M, Mashimo T. Application of a newly designed right-sided, double-lumen endobronchial tube in patients with a very short right mainstem bronchus. Anesthesiology. 2008 Sep;109(3):565-8. doi: 10.1097/ALN.0b013e31818344bd. No abstract available.
- Bussieres JS, Somma J. Modified and newly designed right-sided double-lumen endobronchial tubes are complementary. Anesthesiology. 2009 May;110(5):1190; author reply 1190-1. doi: 10.1097/ALN.0b013e31819fac6a. No abstract available.
- Lohser J, Umedaly HS, Fitzmaurice BG. Do-it-yourself modified right-sided Broncho-Cath double lumen tube. Can J Anaesth. 2007 Aug;54(8):675; author reply 675. doi: 10.1007/BF03022963. No abstract available.
- Fischler M. A call to Mallinckrodt for a modified right-sided Broncho-Cath double lumen tube. Can J Anaesth. 2007 Dec;54(12):1029-30; author reply 1030. doi: 10.1007/BF03016642. No abstract available.
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 (Actual)
August 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 12, 2015
First Submitted That Met QC Criteria
February 12, 2015
First Posted (Estimate)
February 19, 2015
Study Record Updates
Last Update Posted (Actual)
April 10, 2020
Last Update Submitted That Met QC Criteria
April 8, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- IUCPQ-ATB2014
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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