CAPTION AI to Minimize Risk of COVID Exposure

Duke University

Status: Withdrawn

Conditions: COVID-19

Treatments: Device: Caption AI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04336774

pro00105212

Details and patient eligibility

About

Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.

The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.

Full description

To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Duke patients within the MICU and COVID overflow areas
• transthoracic echocardiogram ordered by their provider
• suspected or positive for COVID-19.
• Patients who consent to participating in the study or Physician discretion that information to be gained is important to the patient
• Patients ≥18 years old

Exclusion criteria

• Unable to lie flat for study
• Patients unwilling to give consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Echocardiogram patients

Experimental group

Description:

Patients scheduled to have an echocardiogram (echo) and who are also being evaluated for, or are positive for COVID-19.

Treatment:

Device: Caption AI