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Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries

Primary Purpose

Laryngeal Injuries

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
90 degrees rotation
180 degrees rotation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngeal Injuries focused on measuring during double-lumen, tube intubation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

90 degrees rotation

180 degrees rotation

Arm Description

Double-lumen tube intubation with 90 degrees rotation

Double-lumen tube intubation with 180 degrees rotation

Outcomes

Primary Outcome Measures

postoperative hoarseness

Secondary Outcome Measures

postoperative sore throat

Full Information

First Posted
September 25, 2011
Last Updated
February 16, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01441362
Brief Title
Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries
Official Title
A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Injuries
Keywords
during double-lumen, tube intubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
90 degrees rotation
Arm Type
Active Comparator
Arm Description
Double-lumen tube intubation with 90 degrees rotation
Arm Title
180 degrees rotation
Arm Type
Experimental
Arm Description
Double-lumen tube intubation with 180 degrees rotation
Intervention Type
Procedure
Intervention Name(s)
90 degrees rotation
Intervention Description
Double-lumen tube intubation with 90 degrees rotation
Intervention Type
Procedure
Intervention Name(s)
180 degrees rotation
Intervention Description
Double-lumen tube intubation with 180 degrees rotation
Primary Outcome Measure Information:
Title
postoperative hoarseness
Time Frame
up to 3 days
Secondary Outcome Measure Information:
Title
postoperative sore throat
Time Frame
up to 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23794671
Citation
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.
Results Reference
derived

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Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries

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