Double Lumen TubeNCT03378180
Measurement of Tracheobronchial Tree Using 3D CT
An observational study of Double Lumen Tube and Computed Tomography, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left main endobronchial lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Double Lumen Tube, Computed Tomography
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Dec 2017to 30 Mar 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: retrospective measurement of 3D CT scan images obtained from patients admitted for thoracic surgery
Who may be able to join
- 3D- thoracic CT scan images obtained between March 1st and October 31th, 2016
Who cannot join
- younger than 18
- with intraluminal lesions in main bronchus
- with abnormalities of tracheobronchial tree
- with history of tracheobronchial injury or surgery
- diagnosed musculoskeletal deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Tracheobronchial Tree Using Multiplane CT Reconstructions to Guide Selecting Double-lumen Tubes
Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left main endobronchial lesions.
With recent advances of 3-dimensional spiral CT reconstruction technique, the investigators conducted this retrospective study to measure accurate length of right and left main bronchus and the angle between the center of the right main bronchus and right upper lobe orifice in axial image to help choosing and further manufacturing right-sided double-lumen tubes.
Read the detailed description
All CT images will be reviewed using the image measurement software with a slice thickness of 1 mm. A level of -450 Hounsfield units and a width of 1000 Hounsfield units were used for bronchial window settings.
The length of right and left main bronchus will be measured from the tracheal bifurcation to the point of their first branches, respectively, in both 2D- and 3D-CT images. The anteroposterior angulation of right upper lobar bronchus will be measured from the axial 2D-images by the angle between the horizontal midline of the right main bronchus and the center of the RUL orifice which indicates the origin of the RUL bronchus in which the right upper lobar bronchus shows maximal diameter.
- Conditions
- Double Lumen Tube, Computed Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
right upper lobe orifice
the angle between the center of the right main bronchus and right upper lobe orifice in axial image
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
length of right and left main bronchus
accurate length of both main stem bronchi measured by 3D CT
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start25 Dec 2017 (estimated)
- Primary completion20 Feb 2018 (estimated)
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Lumen TubeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378180
- Sponsor's protocol ID
- JHBahk_RUA
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Tracheobronchial Tree Using Multiplane CT Reconstructions to Guide Selecting Double-lumen Tubes
- ClinicalTrials.gov ID
- NCT03378180
- Acronym / sponsor ID
- JHBahk_RUA
- Conditions
- Double Lumen Tube, Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Dec 2017 (estimated)
- Primary completion
- 20 Feb 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 19 Dec 2017 (actual)
- 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.
Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left main endobronchial lesions.
With recent advances of 3-dimensional spiral CT reconstruction technique, the investigators conducted this retrospective study to measure accurate length of right and left main bronchus and the angle between the center of the right main bronchus and right upper lobe orifice in axial image to help choosing and further manufacturing right-sided double-lumen tubes.
Detailed description
All CT images will be reviewed using the image measurement software with a slice thickness of 1 mm. A level of -450 Hounsfield units and a width of 1000 Hounsfield units were used for bronchial window settings.
The length of right and left main bronchus will be measured from the tracheal bifurcation to the point of their first branches, respectively, in both 2D- and 3D-CT images. The anteroposterior angulation of right upper lobar bronchus will be measured from the axial 2D-images by the angle between the horizontal midline of the right main bronchus and the center of the RUL orifice which indicates the origin of the RUL bronchus in which the right upper lobar bronchus shows maximal diameter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective measurement of 3D CT scan images obtained from patients admitted for thoracic surgery
Key inclusion criteria (1 listed)
- 3D- thoracic CT scan images obtained between March 1st and October 31th, 2016
Key exclusion criteria (5 listed)
- younger than 18
- with intraluminal lesions in main bronchus
- with abnormalities of tracheobronchial tree
- with history of tracheobronchial injury or surgery
- diagnosed musculoskeletal deformity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
right upper lobe orifice
Time frame: through study completion, an average of 1 year
the angle between the center of the right main bronchus and right upper lobe orifice in axial image
1 secondary outcome
length of right and left main bronchus
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double Lumen Tube and Computed Tomography, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
right upper lobe orifice (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.