Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- middle ear status
研究概览
简要总结
This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.
详细描述
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.
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
- 3 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-6 years old
- •History of chronic otitis media with effusion(OME)
- •Scheduled or within 6 weeks of tube insertion
- •OME at entry or surgery
- •Generally good health
排除标准
- •Cleft palate or other syndromes predisposing to OM
- •History of recurrent acute otitis media only
- •History of complications of OM or its treatment
- •Unable to cooperate for testing
结局指标
主要结局
middle ear status
时间窗: 12 months
middle-ear status at 12 months after tympanostomy tube became non-functional
次要结局
未报告次要终点
研究者
Ellen M. Mandel
Associate Professor
University of Pittsburgh
