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A Novel Objective Diagnostic Test for Otitis Media With Effusion

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ClinicalTrials.gov Identifier: NCT02179541
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Nazan Degirmenci, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment
Otitis Media With Effusion Other: RGB

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: RGB Measurements as a Novel Objective Diagnostic Test for Otitis Media With Effusion
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Group/Cohort Intervention/treatment
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
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 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
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 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
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 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
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.




Primary Outcome Measures :
  1. Mean RGB values [ Time Frame: January-May 2013 (5 months) ]


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179541


Locations
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Turkey
Bezmialem Vakif University
Istanbul, Fatih, Turkey, 34093
Sponsors and Collaborators
Nazan Degirmenci
Investigators
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Principal Investigator: Selahattin TUGRUL Bezmialem Vakif University
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Responsible Party: Nazan Degirmenci, M.D, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT02179541    
Other Study ID Numbers: B.30.2.BAV.0.05.05/467
B.30.2.BAV.0.05.05/467 ( Other Identifier: Bezmialem Vakif University )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: January 2013
Keywords provided by Nazan Degirmenci, Bezmialem Vakif University:
Otitis media with effusion, viscosity, RGB (red-green-blue).
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases