Ear Infection, Middle Ear Infection, Otitis Media
Conditions
Keywords
Otoscope, Tympanogram
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.
Interventions
DEVICEThe OtoSight Middle Ear Scope
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.
Sponsors
Baylor College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exam Completion Rate | 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. |
| Detection of middle ear fluid | 6 months | Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools. |
| Categorization of middle ear fluid | 6 months | Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Evaluation of Clinic Flow | 6 months | 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. |
Countries
United States
Outcome results
None listed