Diagnostic Utility of Otosight Middle Ear Scope

Study Overview
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Brief Summary
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Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

Detailed Description
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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.

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

Conditions
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Ear Infection, Middle Ear Infection, Otitis Media

Intervention / Treatment
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* Device: The OtoSight Middle Ear Scope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Otosight, Otoscope, and Tympanogram<br>Prospective study using a convenience sample. There will be no group assignment or randomization. There is no intervention planned and therefore, no placebo group or use of controls. | Device: The OtoSight Middle Ear Scope<br>* The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exam Completion Rate | 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. | 6 months | 
| Detection of middle ear fluid | Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools. | 6 months | 
| Categorization of middle ear fluid | Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Evaluation of Clinic Flow | Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic by timing how long it takes for the MA and/or MD to complete the Otosight exam. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otoscope, Tympanogram