Endotracheal IntubationNCT06061055
Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition
A study testing Intubation with VentiBronc Anchor endobronchial double-lumen tube and conventional double-lumen intubation in people with Endotracheal Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Intubation with VentiBronc Anchor endobronchial double-lumen tube and conventional double-lumen intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2023to 26 Nov 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring left double-lumen endotracheal tube intubation for thoracic surgery.
- ASA physical status classification 2-4. Female patients aged 20-85 with a height of 160cm or less and a body mass index (BMI) of 25.0 kg/m2 or higher.
- Patients requiring VentiBroncTM Anchor 33Fr or Shiley® 32Fr intubation due to a left mainstem bronchus diameter of 11mm or less on chest CT.
Who cannot join
- Intraluminal lesions in the left or right mainstem bronchi. History of airway surgery. Emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. The aim of this study is to determine if the use of VentiBroncTM Anchor increases the success rate of optimal double-lumen intubation to left main bronchus.
- Conditions
- Endotracheal Intubation
- Being tested
- Intubation with VentiBronc Anchor endobronchial double-lumen tube, conventional double-lumen intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with VentiBronc Anchor endobronchial double-lumen tubeDevice
Patients in this group are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor).
conventional double-lumen intubationDevice
Patients in this group are intubated with conventional double-lumen endobronchial tube (Shiley).
| Study group | Role | What they receive |
|---|---|---|
| Anchor | Experimental | Patient group who are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor) Receives: Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube |
| Shiley | Active comparator | Patient group who are intubated with conventional double-lumen endobronchial tube (Shiley) Receives: Device: conventional double-lumen intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of endobronchial intubation
Success or failure of endobronchial intubation will be determined immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope.
Measured: Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start26 Oct 2023
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyuho Lee, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061055
- Sponsor's protocol ID
- 1-2023-0043
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim N, Oh YJ, Kim HJ, Lee K. Novel Triple-Cuff versus Conventional Double-Cuff Double-Lumen Endobronchial Tube in Patients with Risk Factors for Tube Misdirection. Yonsei Med J. 2025 Dec;66(12):866-873. doi: 10.3349/ymj.2025.0060.
PubMed 41287499
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition
- ClinicalTrials.gov ID
- NCT06061055
- Acronym / sponsor ID
- 1-2023-0043
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 29 Sep 2023 (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 investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. The aim of this study is to determine if the use of VentiBroncTM Anchor increases the success rate of optimal double-lumen intubation to left main bronchus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anchor | Experimental | Device: Intubation with VentiBronc Anchor endobronchial double-lumen tubePatient group who are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor) |
| Shiley | Active comparator | Device: conventional double-lumen intubationPatient group who are intubated with conventional double-lumen endobronchial tube (Shiley) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring left double-lumen endotracheal tube intubation for thoracic surgery.
- ASA physical status classification 2-4. Female patients aged 20-85 with a height of 160cm or less and a body mass index (BMI) of 25.0 kg/m2 or higher.
- Patients requiring VentiBroncTM Anchor 33Fr or Shiley® 32Fr intubation due to a left mainstem bronchus diameter of 11mm or less on chest CT.
Key exclusion criteria (1 listed)
- Intraluminal lesions in the left or right mainstem bronchi. History of airway surgery. Emergency surgery.
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 |
|---|---|---|
| Intubation with VentiBronc Anchor endobronchial double-lumen tubePatients in this group are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor). | Device | Anchor |
| conventional double-lumen intubationPatients in this group are intubated with conventional double-lumen endobronchial tube (Shiley). | Device | Shiley |
Primary outcome
Success rate of endobronchial intubation
Time frame: Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope
Success or failure of endobronchial intubation will be determined immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope.
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 12 Dec 2024.
- Derived from this study: PubMed 41287499Kim N, Oh YJ, Kim HJ, Lee K. Novel Triple-Cuff versus Conventional Double-Cuff Double-Lumen Endobronchial Tube in Patients with Risk Factors for Tube Misdirection. Yonsei Med J. 2025 Dec;66(12):866-873. doi: 10.3349/ymj.2025.0060.
- Individual participant dataSharing planned: No
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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.
Kyuho Lee principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation with VentiBronc Anchor endobronchial double-lumen tube and conventional double-lumen intubation in people with Endotracheal Intubation, run by Yonsei University 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 3 inclusion and 1 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 12 Dec 2024. 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?
Success rate of endobronchial intubation (time frame: Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061055, which also lists 1 linked publication.
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 12 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.