Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
研究概览
简要总结
For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system.
A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.
详细描述
A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear.
The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital
- •Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears
排除标准
- •Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum
- •Changing the pathology of the ear canal or middle ear in the same visit
- •Trauma after otoscopic examination
- •can not record or focus the entire view of the eardrum by both otoscopes
结局指标
主要结局
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
时间窗: 6 months
Cohen's kappa coefficient
次要结局
未报告次要终点
研究者
Suwicha Isaradisaikul Kaewsiri
Principal Investigator
Chiang Mai University