Back to resultsThermosoftening of Double-lumen Tube for Airway Exchanger Catheter
Primary Purpose
Intubation Complication, Hoarseness, Sore Throat
Status
Unknown status
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 Intubation Complication focused on measuring double-lumen tube, intubation, airway exchange catheter, thermosoftening
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes
Exclusion Criteria:
- Preoperative hoarseness or a sore throat
- History of upper airway diseases
- Anticipated difficult airway
Sites / Locations
- Seoul National University HospitalRecruiting
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
Time to intubate
Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.
Secondary Outcome Measures
Postoperative hoarseness (4-points scoring)
postoperative sore throat (4-points scoring)
Vocal cord injuries assessed by videolaryngoscope
vocal cord injuries observed after tube-exchange
Full Information
NCT ID
NCT03846713
First Posted
January 9, 2019
Last Updated
February 18, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03846713
Brief Title
Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter
Official Title
Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, Hoarseness, Sore Throat
Keywords
double-lumen tube, intubation, airway exchange catheter, thermosoftening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (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
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
Intervention Type
Procedure
Intervention Name(s)
thermosoftening
Intervention Description
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).
Primary Outcome Measure Information:
Title
Time to intubate
Description
Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.
Time Frame
Intraoperative (During exchanging single- to double-lumen tube)
Secondary Outcome Measure Information:
Title
Postoperative hoarseness (4-points scoring)
Time Frame
up to 48 hours after surgery
Title
postoperative sore throat (4-points scoring)
Time Frame
up to 48 hours after surgery
Title
Vocal cord injuries assessed by videolaryngoscope
Description
vocal cord injuries observed after tube-exchange
Time Frame
up to 1 hour after double-lumen tube extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes
Exclusion Criteria:
Preoperative hoarseness or a sore throat
History of upper airway diseases
Anticipated difficult airway
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Hyon Bahk, MD, PhD
Phone
82-2-2072-2818
Email
bahkjh@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Susie Yoon, MD
Phone
82-2-2072-7361
Email
susiey87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Hyon Bahk, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hyon Bahk, PhD, MD
Phone
82-2-2072-2818
Email
bahkjh@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Susie Yoon, MD
Phone
82-2-2072-7361
Email
susiey87@gmail.com
First Name & Middle Initial & Last Name & Degree
Jae-Hyon Bahk, PhD, MD
12. IPD Sharing Statement
Learn more about this trial
Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter
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