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Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion

Primary Purpose

Lung Surgery

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

About this trial

This is an interventional prevention trial for Lung Surgery focused on measuring intubation, pharyngitis

Eligibility Criteria

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

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

Sites / Locations

  • Keimyung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Two-hand

Arm Description

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
Visual anlogue 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 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

First Posted
November 1, 2017
Last Updated
March 15, 2019
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03331809
Brief Title
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion
Official Title
Influence of Two-handed Jaw Thrust on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Two-hand
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Two-handed jaw thrust
Intervention Description
The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.
Intervention Type
Procedure
Intervention Name(s)
Conventional intubation
Intervention Description
The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.
Primary Outcome Measure Information:
Title
Number of participants with postoperative sore throat for postoperative 24 h
Time Frame
At 24 hr
Secondary Outcome Measure Information:
Title
Number of participants with postoperative sore throat
Time Frame
At 1, 6, and 24 hr
Title
Postoperative sore throat scores
Description
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Time Frame
At 1, 6, and 24 hr
Title
Number of participants with postoperative hoarseness
Time Frame
At 1, 6, and 24 hr
Title
Number of participants with postoperative shivering
Time Frame
At 1, 6, and 24 hr
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 hr
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 hr

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 3 Recent sore throat Cervical spine disease History of head and neck surgery
Facility Information:
Facility Name
Keimyung University
City
Daegu
State/Province
Non-US/Canada
ZIP/Postal Code
137-040
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31860598
Citation
Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
Results Reference
derived

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Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion

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