- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01441362
Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries
February 16, 2012 updated by: Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
Exclusion Criteria:
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Operation time longer than 6 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 90 degrees rotation
Double-lumen tube intubation with 90 degrees rotation
|
Double-lumen tube intubation with 90 degrees rotation
|
|
Experimental: 180 degrees rotation
Double-lumen tube intubation with 180 degrees rotation
|
Double-lumen tube intubation with 180 degrees rotation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative hoarseness
Time Frame: up to 3 days
|
up to 3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative sore throat
Time Frame: up to 3 days
|
up to 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
September 25, 2011
First Submitted That Met QC Criteria
September 26, 2011
First Posted (Estimate)
September 27, 2011
Study Record Updates
Last Update Posted (Estimate)
February 20, 2012
Last Update Submitted That Met QC Criteria
February 16, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JHBahk_DLT_180
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.