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RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image

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ClinicalTrials.gov Identifier: NCT03070288
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:

The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR).

All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.


Condition or disease Intervention/treatment
Allergic Rhinitis Other: Red-green-blue measurements of nasal mucosa image

Detailed Description:
This study enrolled 73 patients with AR (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens. All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Each image was marked with standardized points at the anterior part of the nasal mucosa on both sides (2 points each right and left sides of the anterior septum and 2 points each anterior part of the inferior turbinates). These points were numbered 1 and 2 over the right inferior turbinate; 3 and 4 over the right side of the anterior septum; 4 and 5 over the left inferior turbinate; 6 and 7 over the left side of the anterior septum. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.

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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Group/Cohort Intervention/treatment
Group 1
Red-green-blue measurements of nasal mucosa images of patients with allergic rhinitis
Other: Red-green-blue measurements of nasal mucosa image
Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area

Group 2
Red-green-blue measurements of nasal mucosa images of normal healthy individuals
Other: Red-green-blue measurements of nasal mucosa image
Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area




Primary Outcome Measures :
  1. The difference of nasal mucosa color between groups [ Time Frame: 3 months ]
    Nasal mucosa colors of the groups were measured with the numerical values of the RGB color components. All endoscopic photographs of the septum and both inferior turbinates of the patients and healthy individuals were taken while the examination at the outpatient clinic for three months. Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the pointed area. Color discoloration at the nasal mucosa of allergic patients compared with the healthy individuals by using RGB measurements.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This study enrolled 73 patients with allergic rhinitis (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens.
Criteria

Inclusion Criteria:

  • Subject has positive skin prick test results
  • Subject has more than 5 points of Lebel Symptom Score Scale
  • Subjects between 18-60 ages
  • Subjects with allergic rhinitis

Exclusion Criteria:

  • Negative skin prick test results
  • Acute respiratory tract infection existence
  • Scores less than 5 points of Lebel Symptom Score Scale

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): NCT03070288


Locations
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Turkey
Bezmialem Vakif University
Istanbul, Fatih, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Study Chair: Orhan Ozturan Bezmialem Vakif University

Publications:
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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03070288     History of Changes
Other Study ID Numbers: B.30.2.BAV.0.05.05/397
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bezmialem Vakif University:
RGB
red-green-blue
rhinitis
allergic rhinitis
nasal mucosa

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases