Wideband Tympanometry in Otitis Media With Effusion

Pamukkale University

Status: Completed

Conditions: Otitis Media With Effusion

Treatments: Diagnostic Test: Wideband Tympanometry

Study type: Observational

Funder types: Other

Identifiers

NCT04395261

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

202 participants in 5 patient groups

Group 0

Description:

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

Treatment:

Diagnostic Test: Wideband Tympanometry

Group 1

Description:

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

Treatment:

Diagnostic Test: Wideband Tympanometry

Group 2

Description:

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

Treatment:

Diagnostic Test: Wideband Tympanometry

Group 3

Description:

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

Treatment:

Diagnostic Test: Wideband Tympanometry

Group 4

Description:

Control group. Subjects with no otitis media with effusion

Treatment:

Diagnostic Test: Wideband Tympanometry