Spectroscopic Evaluation of Middle Ear Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Middle Ear Exam
研究概览
简要总结
Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.
详细描述
The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/ female at all age- newborn to adult.
- •Non- pregnant woman.
- •Diagnose of middle ear infection and plan for surgery procedure.
排除标准
- •Pregnant woman
- •Incompetent adults (i.e. individuals with cognitive impairment)
- •No diagnose of middle ear infection and no plan for surgery procedure.
- •Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
研究组 & 干预措施
Medical Tool
Spectroscopic otoscope
干预措施: Spectroscopic otoscope measurements (Device)
结局指标
主要结局
Middle Ear Exam
时间窗: 5 minutes
The level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable.
次要结局
未报告次要终点
研究者
Elliot L Botvinick
Professor of Biomedical Engineering and Surgery
University of California, Irvine