The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus

May 20, 2015 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1540

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:

  • Abnormal anatomy of tracheobronchial tree
  • Intraluminal lesion in the left or right 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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutral shape of bronchial tip
Device: Neutral shape of bronchial tip
Intubation is performed without transforming the shape of the bonchial tipof a double lumen tube.
Experimental: Bent shape of bronchial tip
Device: Bent shape of bronchial tip
Intubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with intubation to right mainstem bronchus
Time Frame: An expected average of 5minutes after intubation
An expected average of 5minutes after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with airway injury
Time Frame: An expected average of 5 minutes after bilateral lung ventilation
An expected average of 5 minutes after bilateral lung ventilation

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

March 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

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_flexion

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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