Thermosoftening of Double-lumen Tube to Reduce Sore Throat
The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 18, 2012
December 1, 2012
7 months
June 20, 2012
December 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative hoarseness
up to 3 days after surgery
postoperative sore throat
up to 3 days after surgery
Secondary Outcomes (1)
Vocal cord injuries
up to 1 day after surgery
Study Arms (2)
non-thermosoftening
ACTIVE COMPARATORDouble-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
thermosoftening
EXPERIMENTALDouble-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
Interventions
Intubation is performed with a double-lumen tube put into normal saline at room temperature.
Intubation is performed with a double lumen tube put into warm normal saline (40°C).
Eligibility Criteria
You may qualify if:
- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
You may not qualify if:
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Anesthesia time longer than 6 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 26787799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 20, 2012
First Posted
June 22, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 18, 2012
Record last verified: 2012-12