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CompletedNCT03846713Updated Jun 25, 2025

Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter

An interventional study of non-thermosoftening and thermosoftening in Intubation Complication, Hoarseness and Sore Throat, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2017, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Intubation Complication
  • Hoarseness
  • Sore Throat

Keywords

  • double-lumen tube
  • intubation
  • airway exchange catheter
  • thermosoftening
03

In context

Hoarseness

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 102 is close to the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Preoperative hoarseness or a sore throat
  • History of upper airway diseases
  • Anticipated difficult airway
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • 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

  • Experimental
    thermosoftening

    Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.

    Procedure: thermosoftening

Interventions

  • Procedurenon-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.

  • Procedurethermosoftening

    By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

06

What researchers measure

Primary outcomes

  1. Time to intubate

    Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.

    Time frame: Intraoperative (During exchanging single- to double-lumen tube)

Secondary outcomes

  1. Postoperative hoarseness (4-points scoring)

    Time frame: up to 48 hours after surgery

  2. postoperative sore throat (4-points scoring)

    Time frame: up to 48 hours after surgery

  3. Vocal cord injuries assessed by videolaryngoscope

    vocal cord injuries observed after tube-exchange

    Time frame: up to 1 hour after double-lumen tube extubation

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Seoul 110-744, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Mar 2019, 15 months.

Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 15 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2019
First posted
Feb 20, 2019
StartActual
Dec 27, 2017
Primary completionActual
Mar 31, 2019
CompletionActual
May 31, 2019
Last update
Jun 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03846713
Responsible party
Jae-Hyon Bahk, MD, PhD (Professor, Seoul National University Hospital) — Principal investigator
First posted
Feb 20, 2019
Start date
Dec 27, 2017
Primary completion
Mar 31, 2019
Completion
May 31, 2019
Last update
Jun 25, 2025

Study contacts

Jae-Hyon Bahk, MD, PhD
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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