Clinical trial NCT05813119: Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology
Official title: Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Middle Ear Disease
Diagnosis
Keywords: Middle Ear Disease
otoscope
Diagnosis
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit at ENT clinic, Chiang Mai University Hospital

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
timeFrame: 6 months
measure: efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
Study officials:
affiliation: Department of Otolaryngology , Faculty of Medicine, Chiang Mai University
name: Suwicha K Isaradisaikul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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: 10.1177/0009922818812480. Epub 2018 Nov 21.