NCT03378180

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

December 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

December 11, 2017

Last Update Submit

December 17, 2017

Conditions

Double Lumen TubeComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • length of right and left main bronchus

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 19, 2017

Study Start

December 25, 2017

Primary Completion

February 20, 2018

Study Completion

March 30, 2018

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

KR(1)