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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 bronchus
Measurement of the length of the right main stem bronchus on CT-Scan
Procedure: Measurement of the right upper lobe bronchus antero-posterior angulation
Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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