Thoracic CT-scanATBNCT02366455
New Measures for Tracheobronchial Anatomy
An observational study of Thoracic CT-scan and Right Upper Lobe Anatomy, run by Laval University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic CT-scan, Right Upper Lobe Anatomy, Right Sided Double Lumen Endobronchial Tube
- What is being tested?
- Measurement of the length of the right main stem bronchus and Measurement of the right upper lobe bronchus antero-posterior angulation
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Aged 35 to 85 years old
Who cannot join
- 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
About this study
Official title: 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 .
Read the 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.
- Being tested
- Measurement of the length of the right main stem bronchus, Measurement of the right upper lobe bronchus antero-posterior angulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the length of the right main stem bronchusProcedure or surgery
Measurement of the length of the right main stem bronchus on CT-Scan
Measurement of the right upper lobe bronchus antero-posterior angulationProcedure or surgery
Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Measurement of the length of the right main stem bronchus; Procedure: Measurement of the right upper lobe bronchus antero-posterior angulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the length of the right mainstem bronchus
Measured: 1 day
Measure of the right upper lobe bronchus antero-posterior angulation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startAug 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Thoracic CT-scanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Bussières, Laval University
- Investigators
- Jean S. Bussières, M.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366455
- Sponsor's protocol ID
- IUCPQ-ATB2014
- Acronym
- ATB
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2015
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17171882Klein 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.
PubMed 9477054Benumof 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.
PubMed 3674473Benumof 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.
PubMed 17171881Hurford 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.
PubMed 8268428Benumof 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.
PubMed 8268426Campos 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.
PubMed 10702432Ehrenfeld 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.
PubMed 18499621Ehrenfeld 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.
PubMed 19942453Slinger 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.
PubMed 20058114Ikeno 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.
PubMed 8652335Kim 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.
PubMed 23656604Bussieres 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.
PubMed 17400979Hagihira 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.
PubMed 18719454Bussieres 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.
PubMed 19387186
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowing the Right Upper Lobe Anatomy Allows for the Efficient Use of the Right-sided Double Lumen Endobronchial Tube
- ClinicalTrials.gov ID
- NCT02366455
- Acronym / sponsor ID
- ATB / IUCPQ-ATB2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic CT-Scan | – | Procedure: Measurement of the length of the right main stem bronchus, Procedure: Measurement of the right upper lobe bronchus antero-posterior angulationMeasurement 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 |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Aged 35 to 85 years old
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of the length of the right main stem bronchusMeasurement of the length of the right main stem bronchus on CT-Scan | Procedure or surgery | Thoracic CT-Scan |
| Measurement of the right upper lobe bronchus antero-posterior angulationMeasurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan | Procedure or surgery | Thoracic CT-Scan |
Primary outcome
Measurement of the length of the right mainstem bronchus
Time frame: 1 day
Measure of the right upper lobe bronchus antero-posterior angulation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Background: PubMed 17171882McKenna 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.
- Background: PubMed 9477054Klein 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.
- Background: PubMed 3674473Benumof 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.
- Background: PubMed 17171881Benumof 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.
- Background: PubMed 8268428Hurford 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.
- Background: PubMed 8268426Benumof 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.
- Background: PubMed 10702432Campos 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.
- Background: PubMed 18499621Ehrenfeld 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.
- Background: PubMed 19942453Ehrenfeld 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.
- Background: PubMed 20058114Slinger 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.
- Background: PubMed 8652335Ikeno 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.
- Background: PubMed 23656604Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean S. Bussières, M.D. principal investigator
Laval University
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic CT-scan and Right Upper Lobe Anatomy, run by Laval University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the length of the right mainstem bronchus (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366455, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.