RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

Description

The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.

Conditions

Congenital Heart Disease

Study Overview

Study Details

Study overview

The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.

RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

Condition
Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * \<1 years old
  • * Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU
  • * Open Chest
  • * On ECMO
  • * Deemed medically unstable by care team
  • * Cardiology, ICU, hospitalist or bedside nurse concerns

Ages Eligible for Study

to 1 Year

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Gwenyth Fischer, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-04-01