NCT06515808

Brief Summary

Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

July 14, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

GlidescopeMacintosh BladeAirway ScopePostoperative sore throatGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative sore throat (POST)

    POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia.

    12 to 24 hours after general anesthesia is finished

Study Arms (3)

Direct Laryngoscope Group

Patients receiving tracheal intubation with direct laryngoscope

Device: Direct Laryngoscope

GlideScope Group

Patients receiving tracheal intubation with GlideScope

AirwayScope Group

Patients receiving tracheal intubation with AirwayScope

Interventions

Patient receiving tracheal intubation with direct laryngoscope, GlideScope or Airway Scope

Also known as: GlideScope AVL, AirwayScope S100
Direct Laryngoscope Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent inpatient surgeries and general anesthesia with endotracheal tubes, intubated with direct laryngoscope, Pentax AirwayScope or GlideScope, during the period from January 1, 2018, to December 30, 2019, were included for the analysis.

You may qualify if:

  • Patients receiving inpatients surgery and general anesthesia with tracheal intubation

You may not qualify if:

  • Having difficult airway,
  • Anticipated difficult airway:
  • Abnormal cervical spine movement or temporomandibular joint movement
  • Airway-compromising masses such as tumors, cysts, or hematomas
  • A Mallampati score greater than 3
  • A thyromental distance of less than 6 cm
  • A lesion below vocal cord
  • A previously identified difficult airway
  • Unexpected difficult airway
  • difficult mask ventilation
  • difficult vocal cord visualization after multiple attempts of laryngoscopy
  • Receiving laryngeal surgery, such as laryngeal biopsy, laryngeal microsurgery, laryngoplasty or vocal cord surgery,
  • Not being extubated at the end of anesthesia,
  • Being pregnant,
  • Being under 20 years of age,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24300, Taiwan

Location

Related Publications (1)

  • Fu CH, Sung CH. Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the incidence of postoperative sore throat: a cohort study of 9,881 patients. BMC Anesthesiol. 2024 Nov 12;24(1):409. doi: 10.1186/s12871-024-02798-x.

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chao Hsien Sung, MD

    Fu Jen Catholic University Hospital, Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 23, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are not openly available due to institutional privacy guidelines but may be available from the corresponding author upon written request identifying the requestor, and the purpose and proposed use of the shared data.

Locations