Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter
Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter
1 other identifier
interventional
102
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2017
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
December 27, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJune 25, 2025
June 1, 2025
1.3 years
January 9, 2019
June 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to intubate
Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.
Intraoperative (During exchanging single- to double-lumen tube)
Secondary Outcomes (3)
Postoperative hoarseness (4-points scoring)
up to 48 hours after surgery
postoperative sore throat (4-points scoring)
up to 48 hours after surgery
Vocal cord injuries assessed by videolaryngoscope
up to 1 hour after double-lumen tube extubation
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
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).
Eligibility Criteria
You may qualify if:
- Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes
You may not qualify if:
- Preoperative hoarseness or a sore throat
- History of upper airway diseases
- Anticipated difficult airway
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jae-Hyon Bahk, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2019
First Posted
February 20, 2019
Study Start
December 27, 2017
Primary Completion
March 31, 2019
Study Completion
May 31, 2019
Last Updated
June 25, 2025
Record last verified: 2025-06