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临床试验/NCT04395261
NCT04395261已完成不适用

The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry

Pamukkale University0 个研究点目标入组 202 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
主要终点
Absorbance

研究概览

简要总结

The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.

详细描述

Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.

Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.

排除标准

  • The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.

结局指标

主要结局

Absorbance

时间窗: The same 1 day with the operation

Wideband absorbance of frequencies between 250-8000 Hz were measured

Resonance frequency

时间窗: The same 1 day with the operation

Wideband resonance frequency was measured

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

Fazıl Necdet Ardıç

Prof.Dr.

Pamukkale University

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Wideband Tympanometry in Otitis Media With Effusion | 临床试验