search
Back to results

Jaw-thrust on Postoperative Sore Throat

Primary Purpose

General Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Two-handed jaw thrust
Control
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anesthesia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Hyun-Chang Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Two-hand

Arm Description

The attending anesthesiologist provided intubation without two-handed jaw thrust.

The attending anesthesiologist provided intubation with two-handed jaw thrust.

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
Postoperative sore throat scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Number of participants with postoperative hoarseness
Number of participants with postoperative shivering
Wound pain scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Number of participants with jaw discomfort

Full Information

First Posted
June 4, 2018
Last Updated
September 27, 2018
Sponsor
Keimyung University Dongsan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03568279
Brief Title
Jaw-thrust on Postoperative Sore Throat
Official Title
Influence of Two-handed Jaw Thrust on Postoperative Sore Throat
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
August 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
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 two-handed jaw thrust maneuver 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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The attending anesthesiologist provided intubation without two-handed jaw thrust.
Arm Title
Two-hand
Arm Type
Experimental
Arm Description
The attending anesthesiologist provided intubation with two-handed jaw thrust.
Intervention Type
Procedure
Intervention Name(s)
Two-handed jaw thrust
Intervention Description
The assistant applied two-handed jaw thrust for intubation.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
The intubation was done without two-handed jaw thrust.
Primary Outcome Measure Information:
Title
Number of participants with postoperative sore throat for postoperative 24 hour
Time Frame
At postoperative 24 hour
Secondary Outcome Measure Information:
Title
Number of participants with postoperative sore throat
Time Frame
At postoperative 2, 4, and 24 hour
Title
Postoperative sore throat scores
Description
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Time Frame
At postoperative 2, 4, and 24 hour
Title
Number of participants with postoperative hoarseness
Time Frame
At postoperative 2, 4, and 24 hour
Title
Number of participants with postoperative shivering
Time Frame
At postoperative 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 postoperative 2, 4, and 24 hour
Title
Number of participants with jaw discomfort
Time Frame
At postoperative 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
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
Citations:
PubMed Identifier
33535830
Citation
Huh H, Go DY, Cho JE, Park J, Lee J, Kim HC. Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study. J Int Med Res. 2021 Feb;49(2):300060520961237. doi: 10.1177/0300060520961237.
Results Reference
derived

Learn more about this trial

Jaw-thrust on Postoperative Sore Throat

We'll reach out to this number within 24 hrs