- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689127
Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
September 27, 2018 updated by: Hyun-Chang Kim, Keimyung University Dongsan Medical Center
Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyun Chang Kim
- Phone Number: +821028862876
- Email: onidori1979@gmail.com
Study Locations
-
-
Non-US/Canada
-
Daegu, Non-US/Canada, Korea, Republic of, 137-040
- Hyun-Chang Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Heated breathing circuit will be turned off.
|
Heated breathing circuit will be turned off.
|
Experimental: Heat
Heated breathing circuit will be turned on.
|
Heated breathing circuit will be turned on.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with postoperative sore throat for postoperative 24 h
Time Frame: At 24 hours
|
At 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with postoperative sore throat
Time Frame: At 1, 6, and 24 hours
|
At 1, 6, and 24 hours
|
|
Postoperative sore throat scores
Time Frame: At 1, 6, and 24 hours
|
At 1, 6, and 24 hours
|
|
Number of participants with postoperative hoarseness
Time Frame: At 1, 6, and 24 hours
|
At 1, 6, and 24 hours
|
|
Number of participants with postoperative shivering
Time Frame: At 1, 6, and 24 hours
|
At 1, 6, and 24 hours
|
|
Wound pain scores
Time Frame: At 1, 6, and 24 hours
|
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
|
At 1, 6, and 24 hours
|
Jaw discomfort scores
Time Frame: At 1, 6, and 24 hours
|
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
|
At 1, 6, and 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2018
Primary Completion (Anticipated)
November 1, 2019
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
September 27, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
September 28, 2018
Last Update Submitted That Met QC Criteria
September 27, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Heated Circuit POST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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