CT Window Setting to Select Double-lumen Tube Size

May 20, 2015 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

  • Abnoraml anatomy of tracheobronchail tree
  • Intraluminal lesion in the left mainstem bronchus
  • Anticipated difficult intubation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Width 1000 HU/Level -450 HU
Device: Width 1000 HU/Level -450 HU
Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.
Active Comparator: Width 400 HU/Level 25 HU
Device: Width 400 HU/Level 25 HU
Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Air-leak at deflation of bronchial cuff
Time Frame: An expected average of 10 min after double lumen tube intubation
An expected average of 10 min after double lumen tube intubation
Air-tight seal below resting volume of bronchial cuff
Time Frame: An expected average of 10 min after double lumen tube intubation
An expected average of 10 min after double lumen tube intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • JHBahk_DLT_CT window

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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