A Novel Objective Diagnostic Test for Otitis Media With Effusion

NCT02179541 | Completed

• 1 other identifier: B.30.2.BAV.0.05.05/467
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media With Effusion

Keywords

Otitis media with effusion, viscosity, RGB (red-green-blue).

Outcome Measures

Primary Outcomes (1)

• Mean RGB values

  January-May 2013 (5 months)

Study Arms (4)

Group 1

All Group 1 patients were diagnosed with OME, diagnoses made by endoscopic-otoscopic examination findings and type-B tympanograms. They were all scheduled for ventilation tube insertion. Diagnosis of OME was confirmed during this surgery. All patients were examined by 4 mm 0-degree Storz endoscope and light source. The Adobe Photoshop Elements 7.0 program was used for RGB measurements. Viscosity was measured by the Brookfield DV-II+ProCP Viscometer.

Other: RGB

Group 2

Children in Group 2 had totally normal tympanic membranes and type A tympanograms. They had no hearing loss, Eustachian tube dysfunction, or any other ear-related problem, and were included in the study as healthy controls. Excluded from the study were patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with. All subjects were examined by 4 mm 0-degree Storz endoscope and light source. The Adobe Photoshop Elements 7.0 program was used for RGB measurements.

Other: RGB

Group 1a

To determine whether higher or lower viscosity of an effusion impacted RGB values, the patient group was subdivided into two subgroups according to viscosity level. Patients with an effusion below the mean viscosity value of 450 cP (centipoise) were assigned to Group 1a.

Other: RGB

Group 1b

To determine whether higher or lower viscosity of an effusion impacted RGB values, the patient group was subdivided into two subgroups according to viscosity level. Patients with an effusion above the mean viscosity value of 450 cP (centipoise) were assigned to Group 1b.

Other: RGB

Interventions

RGB OTHER

When a circular area of 30 surrounding pixels are placed exactly upon the above-mentioned standardized points, the Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in that area. The RGB values of the same points on the tympanic membrane images of the two groups were obtained and compared. Diagnostic significance of objectively assessed color changes at the tympanic membrane in OME patients was evaluated.

Group 1; Group 1a; Group 1b; Group 2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nazan Degirmenci: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Selahattin TUGRUL

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: July 2, 2014
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 2, 2014

Record last verified: 2013-01

Locations

TU (1)