Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology

Diagnosis Clinical Trial

— otoscopy  

Official title:

Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05813119
• Other study ID #: ENT-2564-08562
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: August 2023
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system. A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.

Description:

A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear. The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital
• Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears

Exclusion Criteria:

• Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum
• Changing the pathology of the ear canal or middle ear in the same visit
• Trauma after otoscopic examination
• can not record or focus the entire view of the eardrum by both otoscopes

Related Conditions & MeSH terms

• Diagnosis
• Disease
• Ear Diseases
• Middle Ear Disease

Locations

Country	Name	City	State
Thailand	Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Bhavana K, Ahmad M, Sharma P. Smartphone Otoscopy Sans Attachment: A Paradigm Shift in Diagnosing Ear Pathologies. OTO Open. 2018 Jul 19;2(3):2473974X18786496. doi: 10.1177/2473974X18786496. eCollection 2018 Jul-Sep. — View Citation

Chan KN, Silverstein A, Bryan LN, McCracken CE, Little WK, Shane AL. Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media. Clin Pediatr (Phila). 2019 Mar;58(3):302-306. doi: 10.1177/0009922818 — View Citation

Moshtaghi O, Sahyouni R, Haidar YM, Huang M, Moshtaghi A, Ghavami Y, Lin HW, Djalilian HR. Smartphone-Enabled Otoscopy in Neurotology/Otology. Otolaryngol Head Neck Surg. 2017 Mar;156(3):554-558. doi: 10.1177/0194599816687740. Epub 2017 Jan 24. — View Citation

Mousseau S, Lapointe A, Gravel J. Diagnosing acute otitis media using a smartphone otoscope; a randomized controlled trial. Am J Emerg Med. 2018 Oct;36(10):1796-1801. doi: 10.1016/j.ajem.2018.01.093. Epub 2018 Jan 31. — View Citation

Rappaport KM, McCracken CC, Beniflah J, Little WK, Fletcher DA, Lam WA, Shane AL. Assessment of a Smartphone Otoscope Device for the Diagnosis and Management of Otitis Media. Clin Pediatr (Phila). 2016 Aug;55(9):800-10. doi: 10.1177/0009922815593909. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology	agreement percentage	6 months
Primary	efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology	Cohen's kappa coefficient	6 months