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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034575
Other study ID # 20-012365
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 29, 2021
Est. completion date February 1, 2022

Study information

Verified date October 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess whether eye-tracking technology can be used to differentiate the visual gaze patterns of experienced and novice laryngoscopists while reviewing prerecorded laryngeal videos with both normal and abnormal findings and to characterize any differences arising between level of training groups.


Description:

Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists. This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers. There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults, age 18 and over. - Already professionals in a laryngology related field, residents in a related field or students considering a related field. - Related fields include otolaryngology, laryngology, and speech language pathology. Exclusion Criteria: - Anyone not meeting the inclusion criteria or anyone not wishing to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Eye Tracking Technology Sensor
Eye tracking will be performed using Tobii Pro eye tracking technology sensor (Tobii Pro Fusion, Stockholm, Sweden), providing binocular eye tracking up to 250 Hz. The sensor, positioned on the inferior aspect of the computer monitor, reflects infrared (IR) light beams off of each cornea and are subsequently captured.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Fixation Fixation Point Defined as the temporary suspension of eye movement (80ms) on a specific point (= 30 pixels) within the field of view. 15 minutes
Primary Percent of Fixation Time on pre determined area of interest Defined as the percent of total gaze time on area of interest 15 minutes
Primary Count of Fixations Number of times observer returns gaze to area of interest 15 minutes
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