- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02179541
A Novel Objective Diagnostic Test for Otitis Media With Effusion
July 1, 2014 updated by: Nazan Degirmenci
RGB Measurements as a Novel Objective Diagnostic Test for Otitis Media With Effusion
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fatih
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Istanbul, Fatih, Turkey, 34093
- Bezmialem Vakif University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
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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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean RGB values
Time Frame: January-May 2013 (5 months)
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January-May 2013 (5 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Selahattin TUGRUL, Bezmialem Vakif University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
May 30, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Estimate)
July 2, 2014
Last Update Submitted That Met QC Criteria
July 1, 2014
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.BAV.0.05.05/467 (Other Identifier: Bezmialem Vakif University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Otitis Media With Effusion
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Bezmialem Vakif UniversityCompleted
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Nationwide Children's HospitalWithdrawn
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Alcon ResearchCompletedOtitis Media With Effusion in Children | Otitis Media Recurrent
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Tusker MedicalCompletedAOM - Acute Otitis Media | OME - Otitis Media With EffusionUnited States, Canada
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