Airway MorbidityNCT01371773
Repositioning Method for Left-sided Double Lumen Tubes
A study testing repositioning method for left-sided double lumen tubes in people with Airway Morbidity and Intubation Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Morbidity, Intubation Complication
- What is being tested?
- repositioning method for left-sided double lumen tubes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Dec 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery that requires the placement of left-sided double lumen tubes
Who cannot join
- intraluminal lesion of left bronchus
- very distorted anatomy of tracheobronchial tree
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: Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus
The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.
- Conditions
- Airway Morbidity, Intubation Complication
- Being tested
- repositioning method for left-sided double lumen tubes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repositioning method for left-sided double lumen tubesProcedure or surgery
When a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube.
| Study group | Role | What they receive |
|---|---|---|
| Left-sided double lumen tube | Experimental | Not described Receives: Procedure: repositioning method for left-sided double lumen tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
repositioning success rate
Measured: up to 10 minutes
Secondary outcomes (1)
anatomic parameters
tracheal diameter, position of carina, angle between trachea and left mainstem bronchus
Measured: up to 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Airway MorbidityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371773
- Sponsor's protocol ID
- JHBAhk_headrot
- Status last verified
- Dec 2011
- First submitted
- 31 May 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Seo JH, Bae JY, Kim HJ, Hong DM, Jeon Y, Bahk JH. Misplacement of left-sided double-lumen tubes into the right mainstem bronchus: incidence, risk factors and blind repositioning techniques. BMC Anesthesiol. 2015 Oct 28;15:157. doi: 10.1186/s12871-015-0138-1.
PubMed 26511934
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus
- ClinicalTrials.gov ID
- NCT01371773
- Acronym / sponsor ID
- JHBAhk_headrot
- Conditions
- Airway Morbidity, Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 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.
The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left-sided double lumen tube | Experimental | Procedure: repositioning method for left-sided double lumen tubes |
Who may qualify
- Ages
- 18 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 the placement of left-sided double lumen tubes
Key exclusion criteria (2 listed)
- intraluminal lesion of left bronchus
- very distorted anatomy of 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 |
|---|---|---|
| repositioning method for left-sided double lumen tubesWhen a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube. | Procedure or surgery | Left-sided double lumen tube |
Primary outcome
repositioning success rate
Time frame: up to 10 minutes
1 secondary outcome
anatomic parameters
Time frame: up to 1 hours
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 8 Dec 2011.
- Derived from this study: PubMed 26511934Seo JH, Bae JY, Kim HJ, Hong DM, Jeon Y, Bahk JH. Misplacement of left-sided double-lumen tubes into the right mainstem bronchus: incidence, risk factors and blind repositioning techniques. BMC Anesthesiol. 2015 Oct 28;15:157. doi: 10.1186/s12871-015-0138-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repositioning method for left-sided double lumen tubes in people with Airway Morbidity and Intubation Complication, 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 2 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 8 Dec 2011. 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?
repositioning success rate (time frame: up to 10 minutes). 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 NCT01371773, 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 8 Dec 2011.