NCT03331809

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

March 18, 2019

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

November 1, 2017

Last Update Submit

March 15, 2019

Conditions

Keywords

intubationpharyngitis

Outcome Measures

Primary Outcomes (1)

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

    At 24 hr

Secondary Outcomes (6)

  • Number of participants with postoperative sore throat

    At 1, 6, and 24 hr

  • Postoperative sore throat scores

    At 1, 6, and 24 hr

  • Number of participants with postoperative hoarseness

    At 1, 6, and 24 hr

  • Number of participants with postoperative shivering

    At 1, 6, and 24 hr

  • Wound pain scores

    At 1, 6, and 24 hr

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR
Procedure: Conventional intubation

Two-hand

EXPERIMENTAL
Procedure: Two-handed jaw thrust

Interventions

The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.

Two-hand

The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Patients scheduled for double-lumen endotracheal intubation

You may not qualify if:

  • Difficult airway
  • Mallampatti scores greater than 3
  • Recent sore throat
  • Cervical spine disease
  • History of head and neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

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
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

December 11, 2017

Primary Completion

May 1, 2018

Study Completion

May 2, 2018

Last Updated

March 18, 2019

Record last verified: 2018-06

Locations