Back to resultsHeated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
Primary Purpose
Lung Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Heated breathing circuit on
Heated breathing circuit off
Sponsored by
About this trial
This is an interventional prevention trial for Lung Surgery focused on measuring intubation, pharyngitis
Eligibility Criteria
Inclusion Criteria:
- ASA I-III
- Patients scheduled for double-lumen endotracheal intubation
Exclusion Criteria:
- Difficult airway
- Mallampatti scores greater than 2
- Recent sore throat
- Cervical spine disease
- Recent upper respiratory infection
- Recent analgesics
- History of head and neck surgery
- Friable teeth
- Multiple intubation attempts
Sites / Locations
- Hyun-Chang Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Heat
Arm Description
Heated breathing circuit will be turned off.
Heated breathing circuit will be turned on.
Outcomes
Primary Outcome Measures
Number of participants with postoperative sore throat for postoperative 24 h
Secondary Outcome Measures
Number of participants with postoperative sore throat
Postoperative sore throat scores
Number of participants with postoperative hoarseness
Number of participants with postoperative shivering
Wound pain scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Jaw discomfort scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Full Information
NCT ID
NCT03689127
First Posted
September 27, 2018
Last Updated
September 27, 2018
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03689127
Brief Title
Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
Official Title
Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Surgery
Keywords
intubation, pharyngitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Heated breathing circuit will be turned off.
Arm Title
Heat
Arm Type
Experimental
Arm Description
Heated breathing circuit will be turned on.
Intervention Type
Device
Intervention Name(s)
Heated breathing circuit on
Intervention Description
Heated breathing circuit will be turned on.
Intervention Type
Device
Intervention Name(s)
Heated breathing circuit off
Intervention Description
Heated breathing circuit will be turned off.
Primary Outcome Measure Information:
Title
Number of participants with postoperative sore throat for postoperative 24 h
Time Frame
At 24 hours
Secondary Outcome Measure Information:
Title
Number of participants with postoperative sore throat
Time Frame
At 1, 6, and 24 hours
Title
Postoperative sore throat scores
Time Frame
At 1, 6, and 24 hours
Title
Number of participants with postoperative hoarseness
Time Frame
At 1, 6, and 24 hours
Title
Number of participants with postoperative shivering
Time Frame
At 1, 6, and 24 hours
Title
Wound pain scores
Description
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Time Frame
At 1, 6, and 24 hours
Title
Jaw discomfort scores
Description
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Time Frame
At 1, 6, and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-III
Patients scheduled for double-lumen endotracheal intubation
Exclusion Criteria:
Difficult airway
Mallampatti scores greater than 2
Recent sore throat
Cervical spine disease
Recent upper respiratory infection
Recent analgesics
History of head and neck surgery
Friable teeth
Multiple intubation attempts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Chang Kim
Phone
+821028862876
Email
onidori1979@gmail.com
Facility Information:
Facility Name
Hyun-Chang Kim
City
Daegu
State/Province
Non-US/Canada
ZIP/Postal Code
137-040
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
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