Wideband Tympanometry in Otitis Media With Effusion

NCT ID: NCT04395261

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Otitis Media With Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 0

Patients were divided into groups according to observation in surgery Empty ear in operation

Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Group 1

Patients were divided into groups according to observation in surgery Serous fluid in operation

Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Group 2

Patients were divided into groups according to observation in surgery Mucoid fluid in operation

Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Group 3

Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation

Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Group 4

Control group. Subjects with no otitis media with effusion

Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Interventions

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Wideband Tympanometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fazıl Necdet Ardıç

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fazıl N Ardıç, MD

Role: PRINCIPAL_INVESTIGATOR

Chief of Department

Other Identifiers

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3

Identifier Type: -

Identifier Source: org_study_id

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