CAPTION AI to Minimize Risk of COVID Exposure

COVID-19 Clinical Trial

— CAPTION AI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04336774
• Other study ID #: pro00105212
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: August 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 9, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Duke Health	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Caption Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patient echos that are not interpretable	Images obtained through the point of care AI machine will be uploaded to the cardiology PACS system and read. If the images are felt to be not interpretable, the echo lab will send a sonographer with a regular echo machine to the patient's room to perform the study.	Up to 1 hour
Primary	Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)	There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm	Up to 1 hour
Primary	Time to acquire images as measured by time stamps		up to 1 hour
Secondary	Percent of agreement between AI calculate LVEF and LVEF read by physician		Up to 24 hours