Intubation ComplicationNCT03846713
Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter
A study testing non-thermosoftening and thermosoftening in people with Intubation Complication and Hoarseness, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intubation Complication, Hoarseness, Sore Throat
- What is being tested?
- non-thermosoftening and thermosoftening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes
Who cannot join
- Preoperative hoarseness or a sore throat
- History of upper airway diseases
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: 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.
- Conditions
- Intubation Complication, Hoarseness, Sore Throat
- Being tested
- non-thermosoftening, thermosoftening
- Keywords
- double-lumen tube, intubation, airway exchange catheter, thermosoftening
- Medical subject headings
- Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-thermosofteningProcedure or surgery
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
thermosofteningProcedure or surgery
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).
| Study group | Role | What they receive |
|---|---|---|
| non-thermosoftening | Active comparator | Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation. Receives: Procedure: non-thermosoftening |
| thermosoftening | Experimental | Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation. Receives: Procedure: thermosoftening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubate
Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.
Measured: Intraoperative (During exchanging single- to double-lumen tube)
Secondary outcomes (3)
Postoperative hoarseness (4-points scoring)
Measured: up to 48 hours after surgery
postoperative sore throat (4-points scoring)
Measured: up to 48 hours after surgery
Vocal cord injuries assessed by videolaryngoscope
vocal cord injuries observed after tube-exchange
Measured: up to 1 hour after double-lumen tube extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start27 Dec 2017
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
- Investigators
- Jae-Hyon Bahk, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846713
- Sponsor's protocol ID
- JHBahk_DLT_AEC
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter
- ClinicalTrials.gov ID
- NCT03846713
- Acronym / sponsor ID
- JHBahk_DLT_AEC
- Conditions
- Intubation Complication, Hoarseness, Sore Throat
- Keywords
- double-lumen tube, intubation, airway exchange catheter, thermosoftening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-thermosoftening | Active comparator | Procedure: non-thermosofteningDouble-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation. |
| thermosoftening | Experimental | Procedure: thermosofteningDouble-lumen tube is put into a bottle of warm normal saline (40°C) before intubation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes
Key exclusion criteria (3 listed)
- Preoperative hoarseness or a sore throat
- History of upper airway diseases
- Anticipated difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-thermosofteningBy using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature. | Procedure or surgery | non-thermosoftening |
| thermosofteningBy using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C). | Procedure or surgery | thermosoftening |
Primary outcome
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.
3 secondary outcomes
Postoperative hoarseness (4-points scoring)
Time frame: up to 48 hours after surgery
postoperative sore throat (4-points scoring)
Time frame: up to 48 hours after surgery
Vocal cord injuries assessed by videolaryngoscope
Time frame: up to 1 hour after double-lumen tube extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Hyon Bahk, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-thermosoftening and thermosoftening in people with Intubation Complication and Hoarseness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to intubate (time frame: Intraoperative (During exchanging single- to double-lumen tube)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.