Double Lumen Tube IntubationNCT01818128
The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus
A study testing Neutral shape of bronchial tip and Bent shape of bronchial tip in people with Double Lumen Tube Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Double Lumen Tube Intubation
- What is being tested?
- Neutral shape of bronchial tip and Bent shape of bronchial tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,540 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Feb 2015
- 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 undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
Who cannot join
- Abnormal anatomy of tracheobronchial tree
- Intraluminal lesion in the left or right mainstem bronchus
- Anticipated difficult intubation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.
- Conditions
- Double Lumen Tube Intubation
- Being tested
- Neutral shape of bronchial tip, Bent shape of bronchial tip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral shape of bronchial tipDevice
Intubation is performed without transforming the shape of the bonchial tipof a double lumen tube.
Bent shape of bronchial tipDevice
Intubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Neutral shape of bronchial tip | Active comparator | Not described Receives: Device: Neutral shape of bronchial tip |
| Bent shape of bronchial tip | Experimental | Not described Receives: Device: Bent shape of bronchial tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with intubation to right mainstem bronchus
Measured: An expected average of 5minutes after intubation
Secondary outcomes (1)
Number of participants with airway injury
Measured: An expected average of 5 minutes after bilateral lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Lumen Tube IntubationStudies 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
- 1,540 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818128
- Sponsor's protocol ID
- JHBahk_DLT_flexion
- Status last verified
- May 2015
- First submitted
- 18 Mar 2013
- Last updated
- 22 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus
- ClinicalTrials.gov ID
- NCT01818128
- Acronym / sponsor ID
- JHBahk_DLT_flexion
- Conditions
- Double Lumen Tube Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Mar 2013 (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 investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral shape of bronchial tip | Active comparator | Device: Neutral shape of bronchial tip |
| Bent shape of bronchial tip | Experimental | Device: Bent shape of bronchial tip |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
Key exclusion criteria (3 listed)
- Abnormal anatomy of tracheobronchial tree
- Intraluminal lesion in the left or right mainstem bronchus
- Anticipated difficult intubation
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 |
|---|---|---|
| Neutral shape of bronchial tipIntubation is performed without transforming the shape of the bonchial tipof a double lumen tube. | Device | Neutral shape of bronchial tip |
| Bent shape of bronchial tipIntubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min. | Device | Bent shape of bronchial tip |
Primary outcome
Number of participants with intubation to right mainstem bronchus
Time frame: An expected average of 5minutes after intubation
1 secondary outcome
Number of participants with airway injury
Time frame: An expected average of 5 minutes after bilateral lung ventilation
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 May 2015.
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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 Neutral shape of bronchial tip and Bent shape of bronchial tip in people with Double Lumen Tube Intubation, 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 May 2015. 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?
Number of participants with intubation to right mainstem bronchus (time frame: An expected average of 5minutes after intubation). 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 22 May 2015.