Wideband Tympanometry in Otitis Media With Effusion
The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry
1 other identifier
observational
202
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedFirst Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedSeptember 15, 2023
September 1, 2023
3 years
May 15, 2020
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Resonance frequency
Wideband resonance frequency was measured
The same 1 day with the operation
Absorbance
Wideband absorbance of frequencies between 250-8000 Hz were measured
The same 1 day with the operation
Study Arms (5)
Group 0
Patients were divided into groups according to observation in surgery Empty ear in operation
Group 1
Patients were divided into groups according to observation in surgery Serous fluid in operation
Group 2
Patients were divided into groups according to observation in surgery Mucoid fluid in operation
Group 3
Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation
Group 4
Control group. Subjects with no otitis media with effusion
Interventions
Eligibility Criteria
children with otitis media with effusion
You may qualify if:
- 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.
You may not qualify if:
- The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fazıl N Ardıç, MD
Chief of Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 20, 2020
Study Start
January 1, 2016
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
Data will be available in the university depository