Laryngeal InjuriesNCT01441362
Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries
A study testing 90 degrees rotation and 180 degrees rotation in people with Laryngeal Injuries, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Laryngeal Injuries
- What is being tested?
- 90 degrees rotation and 180 degrees rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Feb 2012
- 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 75 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
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Operation time longer than 6 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries
The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.
- Conditions
- Laryngeal Injuries
- Being tested
- 90 degrees rotation, 180 degrees rotation
- Keywords
- during double-lumen, tube intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 degrees rotationProcedure or surgery
Double-lumen tube intubation with 90 degrees rotation
180 degrees rotationProcedure or surgery
Double-lumen tube intubation with 180 degrees rotation
| Study group | Role | What they receive |
|---|---|---|
| 90 degrees rotation | Active comparator | Double-lumen tube intubation with 90 degrees rotation Receives: Procedure: 90 degrees rotation |
| 180 degrees rotation | Experimental | Double-lumen tube intubation with 180 degrees rotation Receives: Procedure: 180 degrees rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hoarseness
Measured: up to 3 days
Secondary outcomes (1)
postoperative sore throat
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- 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 Laryngeal InjuriesStudies 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441362
- Sponsor's protocol ID
- JHBahk_DLT_180
- Status last verified
- Feb 2012
- First submitted
- 25 Sep 2011
- Last updated
- 20 Feb 2012
- Results posted
- No
Publications
Seo JH, Kwon TK, Jeon Y, Hong DM, Kim HJ, Bahk JH. Comparison of techniques for double-lumen endobronchial intubation: 90 degrees or 180 degrees rotation during advancement through the glottis. Br J Anaesth. 2013 Nov;111(5):812-7. doi: 10.1093/bja/aet203. Epub 2013 Jun 20.
PubMed 23794671
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries
- ClinicalTrials.gov ID
- NCT01441362
- Acronym / sponsor ID
- JHBahk_DLT_180
- Conditions
- Laryngeal Injuries
- Keywords
- during double-lumen, tube intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Sep 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 the method to reduce laryngeal injuries during double-lumen tube intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 90 degrees rotation | Active comparator | Procedure: 90 degrees rotationDouble-lumen tube intubation with 90 degrees rotation |
| 180 degrees rotation | Experimental | Procedure: 180 degrees rotationDouble-lumen tube intubation with 180 degrees rotation |
Who may qualify
- Ages
- 20 to 75 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 (4 listed)
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Operation time longer than 6 hours
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 |
|---|---|---|
| 90 degrees rotationDouble-lumen tube intubation with 90 degrees rotation | Procedure or surgery | 90 degrees rotation |
| 180 degrees rotationDouble-lumen tube intubation with 180 degrees rotation | Procedure or surgery | 180 degrees rotation |
Primary outcome
postoperative hoarseness
Time frame: up to 3 days
1 secondary outcome
postoperative sore throat
Time frame: up to 3 days
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 20 Feb 2012.
- Derived from this study: PubMed 23794671Seo JH, Kwon TK, Jeon Y, Hong DM, Kim HJ, Bahk JH. Comparison of techniques for double-lumen endobronchial intubation: 90 degrees or 180 degrees rotation during advancement through the glottis. Br J Anaesth. 2013 Nov;111(5):812-7. doi: 10.1093/bja/aet203. Epub 2013 Jun 20.
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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 90 degrees rotation and 180 degrees rotation in people with Laryngeal Injuries, 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 4 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 20 Feb 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.
What does the primary outcome measure?
postoperative hoarseness (time frame: up to 3 days). 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 NCT01441362, 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 20 Feb 2012.