search
Back to results

CAPTION AI to Minimize Risk of COVID Exposure (CAPTION AI)

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caption AI
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring Echocardiogram

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke Health
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echocardiogram patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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
Time to acquire images as measured by time stamps

Secondary Outcome Measures

Percent of agreement between AI calculate LVEF and LVEF read by physician

Full Information

First Posted
April 3, 2020
Last Updated
August 6, 2020
Sponsor
Duke University
Collaborators
Caption Health, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04336774
Brief Title
CAPTION AI to Minimize Risk of COVID Exposure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Technology was approved by FDA before study enrolled subjects
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Caption Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Echocardiogram

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echocardiogram patients
Arm Type
Experimental
Arm Description
Patients scheduled to have an echocardiogram (echo) and who are also being evaluated for, or are positive for COVID-19.
Intervention Type
Device
Intervention Name(s)
Caption AI
Intervention Description
Software program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart.
Primary Outcome Measure Information:
Title
Percent of patient echos that are not interpretable
Description
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.
Time Frame
Up to 1 hour
Title
Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)
Description
There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm
Time Frame
Up to 1 hour
Title
Time to acquire images as measured by time stamps
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
Percent of agreement between AI calculate LVEF and LVEF read by physician
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sreekanth Vemulapallli, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CAPTION AI to Minimize Risk of COVID Exposure

We'll reach out to this number within 24 hrs