Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter

June 19, 2025 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter

The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes

Exclusion Criteria:

  • Preoperative hoarseness or a sore throat
  • History of upper airway diseases
  • Anticipated difficult airway

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-thermosoftening
Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
Procedure: non-thermosoftening
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
Experimental: thermosoftening
Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
Procedure: thermosoftening
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to intubate
Time Frame: Intraoperative (During exchanging single- to double-lumen tube)
Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.
Intraoperative (During exchanging single- to double-lumen tube)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hoarseness (4-points scoring)
Time Frame: up to 48 hours after surgery
up to 48 hours after surgery
postoperative sore throat (4-points scoring)
Time Frame: up to 48 hours after surgery
up to 48 hours after surgery
Vocal cord injuries assessed by videolaryngoscope
Time Frame: up to 1 hour after double-lumen tube extubation
vocal cord injuries observed after tube-exchange
up to 1 hour after double-lumen tube extubation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Jae-Hyon Bahk, MD, PhD, 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 (Actual)

December 27, 2017

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHBahk_DLT_AEC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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