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

NCT05813119 | Completed

• 1 other identifier: ENT-2564-08562
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Middle Ear Disease; Diagnosis

Keywords

Middle Ear Disease; otoscope; Diagnosis

Outcome Measures

Primary Outcomes (2)

• efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology

  agreement percentage

  6 months

• efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology

  Cohen's kappa coefficient

  6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visit at ENT clinic, Chiang Mai University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Chiang Mai, 50200, Thailand

Location

Related Publications (5)

• 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 2015 Jul 7. No abstract available.

  PMID: 26156976 RESULT

• 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.

  PMID: 28118550 RESULT

• 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.

  PMID: 31565683 RESULT

• 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.

  PMID: 29544905 RESULT

• 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.

  PMID: 30463434 RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suwicha K Isaradisaikul, MD

  Department of Otolaryngology , Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: April 14, 2023
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)