Clinical trial NCT04336774: CAPTION AI to Minimize Risk of COVID Exposure
Official title: Use of Caption AI to Perform a Clinically Indicated Transthoracic Echocardiogram in Patients Being Evaluated for or Positive for COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Keywords: Echocardiogram
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Caption Health, Inc.
First posted: 2020-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percent of patient echos that are not interpretable
timeFrame: Up to 1 hour
measure: Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)
timeFrame: Up to 1 hour
measure: Time to acquire images as measured by time stamps
timeFrame: up to 1 hour
Secondary outcomes:
measure: Percent of agreement between AI calculate LVEF and LVEF read by physician
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sreekanth Vemulapallli, MD
role: PRINCIPAL_INVESTIGATOR
References: