Official Title
Use of Caption AI to Perform a Clinically Indicated Transthoracic Echocardiogram in Patients Being Evaluated for or Positive for COVID-19
Brief Summary

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.

Detailed 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.

Withdrawn
COVID-19

Device: Caption AI

Software program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Duke Health
Durham, North Carolina, United States

Duke University Medical Center
Durham, North Carolina, United States

Sreekanth Vemulapallli, MD, Principal Investigator
Duke University

Caption Health, Inc.
NCT Number
Keywords
Echocardiogram
MeSH Terms
COVID-19