Measurement of Tracheobronchial Tree Using 3D CT | NCT03378180

Studies
Measurement of Tracheobronchial Tree Using 3D CT

NCT03378180

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 19, 2017Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Double Lumen Tube
Computed Tomography

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 25, 2017Estimated

Primary Completion Date

Feb 20, 2018Estimated

Completion Date

Mar 30, 2018Estimated

First Submitted Date

Dec 11, 2017

First Submission Date that Met QC Criteria

Dec 17, 2017

First Posted Date

Dec 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2017

Last Update Posted Date

Dec 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae-Hyon Bahk, MD, PhD, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
right upper lobe orifice	the angle between the center of the right main bronchus and right upper lobe orifice in axial image	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
length of right and left main bronchus	accurate length of both main stem bronchi measured by 3D CT	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3D- thoracic CT scan images obtained between March 1st and October 31th, 2016

Exclusion Criteria:

younger than 18
with intraluminal lesions in main bronchus
with abnormalities of tracheobronchial tree
with history of tracheobronchial injury or surgery
diagnosed musculoskeletal deformity.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

retrospective measurement of 3D CT scan images obtained from patients admitted for thoracic surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea