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

Allergic Rhinitis Clinical Trial

Official title:

RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070288
• Other study ID #: B.30.2.BAV.0.05.05/397
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: August 2019
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 10, 2019
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Osada T, Arakawa A, Sakamoto N, Ueyama H, Shibuya T, Ogihara T, Yao T, Watanabe S. Autofluorescence imaging endoscopy for identification and assessment of inflammatory ulcerative colitis. World J Gastroenterol. 2011 Dec 14;17(46):5110-6. doi: 10.3748/wjg.v17.i46.5110. — View Citation

Ozturan O, Dogan R, Yenigun A, Veyseller B, Yildirim YS. Photographic Objective Alterations for Laryngopharyngeal Reflux Diagnosis. J Voice. 2017 Jan;31(1):78-85. doi: 10.1016/j.jvoice.2015.12.021. Epub 2016 Feb 9. — View Citation

Tugrul S, Degirmenci N, Eren SB, Dogan R, Meric Hafiz A, Ozturan O. RGB measurements as a novel objective diagnostic test for otitis media with effusion. Acta Otolaryngol. 2015 Apr;135(4):342-7. doi: 10.3109/00016489.2014.984877. Epub 2015 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of nasal mucosa color between groups	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.	3 months