NCT02366455

Brief 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). 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 .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

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

August 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

February 12, 2015

Last Update Submit

April 8, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Measurement of the length of the right mainstem bronchus

    1 day

  • Measure of the right upper lobe bronchus antero-posterior angulation

    1 day

Study Arms (1)

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

Procedure: Measurement of the length of the right main stem bronchusProcedure: Measurement of the right upper lobe bronchus antero-posterior angulation

Interventions

Measurement of the length of the right main stem bronchus on CT-Scan

Thoracic CT-Scan

Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan

Thoracic CT-Scan

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Aged 35 to 85 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 17171882BACKGROUND
  • 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
  • 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
  • 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.

    PMID: 17171881BACKGROUND
  • 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.

    PMID: 8268428BACKGROUND
  • 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.

    PMID: 8268426BACKGROUND
  • 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.

    PMID: 10702432BACKGROUND
  • 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.

    PMID: 18499621BACKGROUND
  • 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.

    PMID: 19942453BACKGROUND
  • 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.

    PMID: 20058114BACKGROUND
  • 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.

    PMID: 8652335BACKGROUND
  • 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
  • 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.

    PMID: 17400979BACKGROUND
  • 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.

    PMID: 18719454BACKGROUND
  • 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.

    PMID: 19387186BACKGROUND
  • 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.

    PMID: 17666722BACKGROUND
  • 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.

    PMID: 18056217BACKGROUND

Study Officials

  • Jean S. Bussières, M.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

August 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 10, 2020

Record last verified: 2020-04