NCT03568279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

June 4, 2018

Last Update Submit

September 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative sore throat for postoperative 24 hour

    At postoperative 24 hour

Secondary Outcomes (6)

  • Number of participants with postoperative sore throat

    At postoperative 2, 4, and 24 hour

  • Postoperative sore throat scores

    At postoperative 2, 4, and 24 hour

  • Number of participants with postoperative hoarseness

    At postoperative 2, 4, and 24 hour

  • Number of participants with postoperative shivering

    At postoperative 2, 4, and 24 hour

  • Wound pain scores

    At postoperative 2, 4, and 24 hour

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Control

Two-hand

EXPERIMENTAL

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

Procedure: Two-handed jaw thrust

Interventions

The assistant applied two-handed jaw thrust for intubation.

Two-hand
ControlPROCEDURE

The intubation was done without two-handed jaw thrust.

Control

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyun-Chang Kim

Daegu, Non-US/Canada, 137-040, South Korea

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations