Heated Circuit on Sore Throat
Primary Purpose
General Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heated circuit on
Heated circuit off
Sponsored by
About this trial
This is an interventional prevention trial for General Anesthesia focused on measuring pharyngitis, intubation, heat
Eligibility Criteria
Inclusion Criteria:
- ASA I-III
- Patients scheduled for general anesthesia with 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Heat
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with postoperative sore throat for postoperative 24 hour
Secondary Outcome Measures
Number of participants with postoperative sore throat
Number of participants with postoperative hoarseness
Wound pain scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Full Information
NCT ID
NCT03693417
First Posted
October 1, 2018
Last Updated
October 1, 2018
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03693417
Brief Title
Heated Circuit on Sore Throat
Official Title
Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 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
No
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 endotracheal intubation for general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia
Keywords
pharyngitis, intubation, heat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Title
Heat
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Heated circuit on
Intervention Description
Heated circuit will be turned on.
Intervention Type
Device
Intervention Name(s)
Heated circuit off
Intervention Description
Heated circuit will be turned off.
Primary Outcome Measure Information:
Title
Number of participants with postoperative sore throat for postoperative 24 hour
Time Frame
At 24 hour
Secondary Outcome Measure Information:
Title
Number of participants with postoperative sore throat
Time Frame
At 2, 4, and 24 hour
Title
Number of participants with postoperative hoarseness
Time Frame
At 2, 4, and 24 hour
Title
Wound pain scores
Description
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Time Frame
At 2, 4, and 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-III
Patients scheduled for general anesthesia with 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Heated Circuit on Sore Throat
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