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Clinical Trials/NCT04395261
NCT04395261
Completed
N/A

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

Pamukkale University0 sites202 target enrollmentJanuary 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Otitis Media With Effusion
Sponsor
Pamukkale University
Enrollment
202
Primary Endpoint
Absorbance
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 30, 2018
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fazıl Necdet Ardıç

Prof.Dr.

Pamukkale University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Absorbance

Time Frame: The same 1 day with the operation

Wideband absorbance of frequencies between 250-8000 Hz were measured

Resonance frequency

Time Frame: The same 1 day with the operation

Wideband resonance frequency was measured

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