One Lung VentilationNCT01364142
A Blind Maneuver to Position an Endobronchial Blocker
An observational study of One Lung Ventilation and Endobronchial Blocker, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- One Lung Ventilation, Endobronchial Blocker, Thoracic Surgery
- What is being tested?
- endobronchial blocker
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Feb 2012
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing thoracic surgery
Who may be able to join
- patients undergoing thoracic surgery who need one lung ventilation
Who cannot join
- patients who have a lesion in trachea or mainstem bronchi
- severe tracheal deviation
- patients who do not agree to informed consent
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: A Blind Maneuver to Position an Endobronchial
One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.
Read the detailed description
The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.
After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.
- Being tested
- endobronchial blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial blockerProcedure or surgery
After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.
| Study group | Role | What they receive |
|---|---|---|
| thoracic surgery | Patients undergoing thoracic surgery in which one lung ventilation is needed. Receives: Procedure: endobronchial blocker |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionFeb 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, Seoul National University Hospital
- Investigators
- Jae-Hyon Bahk, PhD, MD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364142
- Sponsor's protocol ID
- JHBahk_bronchial blocker
- Status last verified
- Jun 2012
- First submitted
- 31 May 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong DM, Seo JH, Chang Kim H, Nam K, Bahk JH. A novel maneuver to blindly position bronchial blockers. Minerva Anestesiol. 2013 Oct;79(10):1126-31. Epub 2013 May 29.
PubMed 23719651
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind Maneuver to Position an Endobronchial
- ClinicalTrials.gov ID
- NCT01364142
- Acronym / sponsor ID
- JHBahk_bronchial blocker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jun 2011 (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.
One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.
Detailed description
The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.
After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic surgery | – | Procedure: endobronchial blockerPatients undergoing thoracic surgery in which one lung ventilation is needed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing thoracic surgery
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery who need one lung ventilation
Key exclusion criteria (3 listed)
- patients who have a lesion in trachea or mainstem bronchi
- severe tracheal deviation
- patients who do not agree to informed consent
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 |
|---|---|---|
| endobronchial blockerAfter intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly. | Procedure or surgery | thoracic surgery |
Primary outcome
Not reported in the source record.
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 22 Jun 2012.
- Derived from this study: PubMed 23719651Hong DM, Seo JH, Chang Kim H, Nam K, Bahk JH. A novel maneuver to blindly position bronchial blockers. Minerva Anestesiol. 2013 Oct;79(10):1126-31. Epub 2013 May 29.
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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, PhD, MD 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?
An observational study of One Lung Ventilation and Endobronchial Blocker, 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 22 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364142, 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 22 Jun 2012.