Back to resultsThermosoftening of Double-lumen Tube to Reduce Sore Throat
Primary Purpose
Hoarseness, Sore Throat, Vocal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-thermosoftening
thermosoftening
Sponsored by
About this trial
This is an interventional prevention trial for Hoarseness focused on measuring double-lumen tube, intubation, thermosoftening
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
- Anesthesia 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
non-thermosoftening
thermosoftening
Arm Description
Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
Outcomes
Primary Outcome Measures
Postoperative hoarseness
postoperative sore throat
Secondary Outcome Measures
Vocal cord injuries
Full Information
NCT ID
NCT01626365
First Posted
June 20, 2012
Last Updated
December 16, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01626365
Brief Title
Thermosoftening of Double-lumen Tube to Reduce Sore Throat
Official Title
The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarseness, Sore Throat, Vocal Cord Injuries
Keywords
double-lumen tube, intubation, thermosoftening
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
non-thermosoftening
Arm Type
Active Comparator
Arm Description
Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
Arm Title
thermosoftening
Arm Type
Experimental
Arm Description
Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
Intervention Type
Procedure
Intervention Name(s)
non-thermosoftening
Intervention Description
Intubation is performed with a double-lumen tube put into normal saline at room temperature.
Intervention Type
Procedure
Intervention Name(s)
thermosoftening
Intervention Description
Intubation is performed with a double lumen tube put into warm normal saline (40°C).
Primary Outcome Measure Information:
Title
Postoperative hoarseness
Time Frame
up to 3 days after surgery
Title
postoperative sore throat
Time Frame
up to 3 days after surgery
Secondary Outcome Measure Information:
Title
Vocal cord injuries
Time Frame
up to 1 day after surgery
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
Anesthesia time longer than 6 hours
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26787799
Citation
Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
Results Reference
derived
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Thermosoftening of Double-lumen Tube to Reduce Sore Throat
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