A Novel Objective Diagnostic Test for Otitis Media With Effusion

Completed

• Conditions: Otitis Media With Effusion

• Registration Number: NCT02179541
• Lead Sponsor: Nazan Degirmenci

Brief Summary

Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic findings are subjective and not always reliable. As an objective test tympanometric evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate, in OME cases, the correlation of tympanic membrane color changes with the presence and viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.

Detailed Description

Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy controls (Group 2) were taken during their otologic examinations. All patients in Group 1 had hearing loss and were diagnosed with OME after audiological evaluation. Specific points were designated at certain areas on each tympanic membrane, and RGB values of those specific points were measured on the tympanic membrane images of both groups. Additionally, in Group 1 viscosity of each effusion taken by paracentesis during surgery was also measured intraoperatively with a viscometer. Patients with viscosity values lower than 450 cP (centipoise) were subdivided into Group 1a, and those with values higher than 450 cP into Group 1b.

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Study First Posted: 2014-07-02
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients with OME, that had endoscopic-otoscopic examination findings and type-B tympanograms.
• They were all scheduled for ventilation tube insertion.

Exclusion Criteria

• Patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean RGB values	January-May 2013 (5 months)

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey