Otitis Media With EffusionNCT02179541
A Novel Objective Diagnostic Test for Otitis Media With Effusion
An observational study of Otitis Media With Effusion, run by Nazan Degirmenci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- RGB
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Patients with OME, that had endoscopic-otoscopic examination findings and type-B tympanograms.
- They were all scheduled for ventilation tube insertion.
Who cannot join
- Patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Otitis Media With Effusion
- Being tested
- RGB
- Keywords
- Otitis media with effusion, viscosity, RGB (red-green-blue).
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGBOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: RGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean RGB values
Measured: January-May 2013 (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazan Degirmenci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazan Degirmenci, Bezmialem Vakif University
- Investigators
- Selahattin TUGRUL, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179541
- Sponsor's protocol ID
- B.30.2.BAV.0.05.05/467
- Other IDs
- B.30.2.BAV.0.05.05/467
- Status last verified
- Jan 2013
- First submitted
- 30 May 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RGB Measurements as a Novel Objective Diagnostic Test for Otitis Media With Effusion
- ClinicalTrials.gov ID
- NCT02179541
- Acronym / sponsor ID
- B.30.2.BAV.0.05.05/467
- Conditions
- Otitis Media With Effusion
- Keywords
- Otitis media with effusion, viscosity, RGB (red-green-blue).
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Nazan DegirmenciUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: RGBAll 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. |
| Group 2 | – | Other: RGBChildren 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. |
| Group 1a | – | Other: RGBTo 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. |
| Group 1b | – | Other: RGBTo 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Patients with OME, that had endoscopic-otoscopic examination findings and type-B tympanograms.
- They were all scheduled for ventilation tube insertion.
Key exclusion criteria (1 listed)
- Patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGBWhen 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. | Other | Group 1, Group 1a, Group 1b, Group 2 |
Primary outcome
Mean RGB values
Time frame: January-May 2013 (5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selahattin TUGRUL principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion, run by Nazan Degirmenci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean RGB values (time frame: January-May 2013 (5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.