- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331809
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion
March 15, 2019 updated by: Keimyung University Dongsan Medical Center
Influence of Two-handed Jaw Thrust 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 two-handed jaw thrust maneuver in patients undergoing double-lumen endotracheal intubation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
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 Locations
-
-
Non-US/Canada
-
Daegu, Non-US/Canada, Korea, Republic of, 137-040
- Keimyung University
-
-
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 3
- Recent sore throat
- Cervical spine disease
- History of head and neck surgery
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.
|
Experimental: Two-hand
|
The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.
|
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 hr
|
At 24 hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with postoperative sore throat
Time Frame: At 1, 6, and 24 hr
|
At 1, 6, and 24 hr
|
|
Postoperative sore throat scores
Time Frame: At 1, 6, and 24 hr
|
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
|
At 1, 6, and 24 hr
|
Number of participants with postoperative hoarseness
Time Frame: At 1, 6, and 24 hr
|
At 1, 6, and 24 hr
|
|
Number of participants with postoperative shivering
Time Frame: At 1, 6, and 24 hr
|
At 1, 6, and 24 hr
|
|
Wound pain scores
Time Frame: At 1, 6, and 24 hr
|
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
|
At 1, 6, and 24 hr
|
Jaw discomfort scores
Time Frame: At 1, 6, and 24 hr
|
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
|
At 1, 6, and 24 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
December 11, 2017
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 2, 2018
Study Registration Dates
First Submitted
November 1, 2017
First Submitted That Met QC Criteria
November 1, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
March 18, 2019
Last Update Submitted That Met QC Criteria
March 15, 2019
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-11-002
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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