Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Detection of middle ear fluid
研究概览
简要总结
Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patients who have a history of ear tube placement
结局指标
主要结局
Detection of middle ear fluid
时间窗: 6 months
Compare the detection of middle ear fluid (versus no fluid) of these diagnostic tools.
Categorization of middle ear fluid
时间窗: 6 months
Compare the categorization of middle ear fluid (purulent vs. serous vs mucoid) of these diagnostic tools.
Exam Completion Rate
时间窗: 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.
次要结局
- Timed Evaluation of Clinic Flow(6 months)
研究者
Anna Messner
Professor
Baylor College of Medicine