Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media

Baylor College of Medicine1 site in 1 country165 target enrollmentFebruary 21, 2023

ConditionsEar Infection Middle Ear Infection Otitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ear Infection
Sponsor: Baylor College of Medicine
Enrollment: 165
Locations: 1
Primary Endpoint: Detection of middle ear fluid
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

Detailed Description

The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.

Registry

clinicaltrials.gov

Start Date

February 21, 2023

End Date

June 30, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Baylor College of Medicine

Responsible Party

Principal Investigator

Anna Messner

Professor

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

•Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses.

Exclusion Criteria

•Patients who have a history of ear tube placement

Outcomes

Primary Outcomes

Detection of middle ear fluid

Time Frame: 6 months

Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.

Categorization of middle ear fluid

Time Frame: 6 months

Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.

Exam Completion Rate

Time Frame: 6 months

Compare the successful exam completion rate of these three diagnostic tools. For the Otosight device: presence or absence of visible tympanic membrane, and presence or absence of graph indicating fluid/no fluid in the middle ear. For tympanogram: presence or absence of interpretable tracing indicating normal tympanic membrane movement, retracted tympanic membrane, or no movement of tympanic membrane. For the Otoscope: success is visualization of the tympanic membrane versus unable to see tympanic membrane.