CAPTION AI to Minimize Risk of COVID Exposure

NCT04336774 | Withdrawn FDA Device

• 1 other identifier: pro00105212
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

Echocardiogram

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Time to acquire images as measured by time stamps

  up to 1 hour

Secondary Outcomes (1)

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

  Up to 24 hours

Study Arms (1)

Echocardiogram patients

EXPERIMENTAL

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

Device: Caption AI

Interventions

Caption AI DEVICE

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

Echocardiogram patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Caption Health, Inc.: collaborator

Study Sites (2)

Duke Health

Durham, North Carolina, 27710, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sreekanth Vemulapallli, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 9, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)