SWIR Otoscopy Study

Official title

A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis

Overview

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.

Detailed description

Millions of children worldwide obtain an antibiotic prescription for treatment of an ear infection (otitis media), and this has been ranked in the top five conditions for direct medical spending for those under 18 years of age. Otitis media is responsible for the vast majority of tympanostomy tube placements, the most common surgical procedure in the US in children with over 600,000 cases per year. Otitis media is inadequately diagnosed and consequently mistreated. Diagnosis is estimated at 51% for US pediatricians, with over-diagnosis occurring 26% of the time. Accurate diagnosis of otitis media can be an issue as it requires a physician to differentiate between various forms of middle ear conditions. The standard of care (SOC) for diagnosing otitis media is pneumotoscopy by eye or using a white light video otoscope. This technique has advantages, but it suffers from subjective interpretations, especially in the hands of inexperienced practitioners. Our team developed the first otoscope sensitive to short wave infrared (SWIR) light for objective identification of middle ear effusions. The SWIR otoscope collects both the information normally seen by a white light otoscope, and SWIR light. The goal with this research is to evaluate the SWIR otoscope against the white light otoscope currently used as the standard of care diagnostic tool in clinic settings. Patients who are undergoing a tympanostomy tube placement procedure will be eligible for this study. In the operating room, imaging will be performed with the SWIR otoscope, which will gather images of both SWIR data and white light data simultaneously. As part of SOC, patients who come into the operating room for the procedure will have removal of middle ear fluid as part of the procedure. The physician performing the procedure will take note of the presence or absence of middle ear fluid. A different physician and a computer program will analyze the images of the SWIR otoscope for presence or absence of middle ear fluid in the image. These results will be compared with the notes taken during the procedure regarding presence or absence of ear fluid.

Interventions

• Device SWIR device
  A Short Wave Infrared (SWIR) Otoscope will record images for both the SWIR and white light video otoscopes. These images of the middle ear will be recorded in AVI format.

Primary outcome measures

• Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement [Time frame: 30 minutes]

Eligibility criteria

Inclusion criteria

• Ages 1-17
• Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital
• Undergoing tympanostomy tube placement as part of standard of care
• Parents and/or patient has the ability to understand and the willingness to sign a written informed consent form or assent form.

Exclusion criteria

• Patients under 1 year of age or 18 and older
• Participants not meeting the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Stanford University — Palo Alto

Publications

• Martynkina LP, Vengerov IuIu, Bespalova IA, Sergeeva GI, Tikhonenko AS. [Structure of the interphase chromatin in the ciliata Bursaria truncatella macronucleus. II. Loop organization of inactive chromatin clumps]. Mol Biol (Mosk). 1984 Jan-Feb;18(1):272-6. Russian. PMID 6423968
• Kashani RG, Mlynczak MC, Zarabanda D, Solis-Pazmino P, Huland DM, Ahmad IN, Singh SP, Valdez TA. Shortwave infrared otoscopy for diagnosis of middle ear effusions: a machine-learning-based approach. Sci Rep. 2021 Jun 15;11(1):12509. doi: 10.1038/s41598-021-91736-9. PMID 34131163
• Pichichero ME. Diagnostic accuracy, tympanocentesis training performance, and antibiotic selection by pediatric residents in management of otitis media. Pediatrics. 2002 Dec;110(6):1064-70. doi: 10.1542/peds.110.6.1064. PMID 12456901
• Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media. Arch Pediatr Adolesc Med. 2001 Oct;155(10):1137-42. doi: 10.1001/archpedi.155.10.1137. PMID 11576009
• Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, Takata GS. Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review. JAMA. 2010 Nov 17;304(19):2161-9. doi: 10.1001/jama.2010.1651. PMID 21081729
• Grubb MS, Spaugh DC. Treatment failure, recurrence, and antibiotic prescription rates for different acute otitis media treatment methods. Clin Pediatr (Phila). 2010 Oct;49(10):970-5. doi: 10.1177/0009922810370363. Epub 2010 Jun 3. PMID 20522607

Identifiers

NCT: NCT06944795 · IRB 44549 · R01DC021326

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗