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临床试验/NCT00393900
NCT00393900已完成不适用

Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2006年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen M. Mandel

Associate Professor

University of Pittsburgh

研究点 (1)

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