One-lung VentilationNCT02981537
Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance
A study testing two-staged endobronchial blocker insertion and single-staged endobronchial blocker insertion in people with One-lung Ventilation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-lung Ventilation
- What is being tested?
- two-staged endobronchial blocker insertion and single-staged endobronchial blocker insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for lung resection
Who cannot join
- refuse to enroll
- patients with lesions involving mainstem bronchi
- patients with anomalies in tracheobronchial tree
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery.
- Conditions
- One-lung Ventilation
- Being tested
- two-staged endobronchial blocker insertion, single-staged endobronchial blocker insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-staged endobronchial blocker insertionDevice
positioning endobronchial blockers in two-staged method
single-staged endobronchial blocker insertionDevice
positioning endobronchial blockers in traditional single-staged method
| Study group | Role | What they receive |
|---|---|---|
| two-staged | Experimental | positioning endobronchial blockers to appropriate bronchus with two-staged methods Receives: Device: two-staged endobronchial blocker insertion; Device: single-staged endobronchial blocker insertion |
| single-staged | Active comparator | positioning endobronchial blockers with traditional single-staged methods Receives: Device: two-staged endobronchial blocker insertion; Device: single-staged endobronchial blocker insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
location of endobronchial blocker
Measured: immediately after the insertion of blocker by fiberoptic bronchoscope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
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 One-lung VentilationStudies 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
- None (open label)
- Enrolment
- 94 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
- JH Bahk, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981537
- Sponsor's protocol ID
- JHBahk_blocker
- Status last verified
- Jul 2017
- First submitted
- 1 Dec 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
Publications
Min S, Yoon S, Han J, Seo JH, Bahk JH. A novel technique of blindly positioning bronchial blockers for one-lung ventilation: a prospective, randomized, crossover study. J Cardiothorac Surg. 2025 Jan 9;20(1):50. doi: 10.1186/s13019-024-03276-8.
PubMed 39780264
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance
- ClinicalTrials.gov ID
- NCT02981537
- Acronym / sponsor ID
- JHBahk_blocker
- Conditions
- One-lung Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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 find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two-staged | Experimental | Device: two-staged endobronchial blocker insertion, Device: single-staged endobronchial blocker insertionpositioning endobronchial blockers to appropriate bronchus with two-staged methods |
| single-staged | Active comparator | Device: two-staged endobronchial blocker insertion, Device: single-staged endobronchial blocker insertionpositioning endobronchial blockers with traditional single-staged methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for lung resection
Key exclusion criteria (3 listed)
- refuse to enroll
- patients with lesions involving mainstem bronchi
- patients with anomalies in tracheobronchial tree
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 |
|---|---|---|
| two-staged endobronchial blocker insertionpositioning endobronchial blockers in two-staged method | Device | single-staged, two-staged |
| single-staged endobronchial blocker insertionpositioning endobronchial blockers in traditional single-staged method | Device | single-staged, two-staged |
Primary outcome
location of endobronchial blocker
Time frame: immediately after the insertion of blocker by 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 13 Jul 2017.
- Derived from this study: PubMed 39780264Min S, Yoon S, Han J, Seo JH, Bahk JH. A novel technique of blindly positioning bronchial blockers for one-lung ventilation: a prospective, randomized, crossover study. J Cardiothorac Surg. 2025 Jan 9;20(1):50. doi: 10.1186/s13019-024-03276-8.
Related trials for One-lung Ventilation
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
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.
JH Bahk principal investigator
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 two-staged endobronchial blocker insertion and single-staged endobronchial blocker insertion in people with One-lung Ventilation, 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 13 Jul 2017. 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?
location of endobronchial blocker (time frame: immediately after the insertion of blocker by 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 NCT02981537, 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 13 Jul 2017.