Clinical trial NCT02179541: A Novel Objective Diagnostic Test for Otitis Media With Effusion
Official title: RGB Measurements as a Novel Objective Diagnostic Test for Otitis Media With Effusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media With Effusion
Keywords: Otitis media with effusion, viscosity, RGB (red-green-blue).
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy controls (Group 2) were taken during their otologic examinations. RGB values of 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean RGB values
timeFrame: January-May 2013 (5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Selahattin TUGRUL
role: PRINCIPAL_INVESTIGATOR
References: