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

University of Minnesota (UMN)

Status: Active, not recruiting

Conditions: Congenital Heart Disease

Treatments: Device: RAPID

Study type: Observational

Funder types: Other

Identifiers

NCT06281639

PEDS-2023-32532

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <1 years old
• Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU

Exclusion criteria

• Open Chest
• On ECMO
• Deemed medically unstable by care team
• Cardiology, ICU, hospitalist or bedside nurse concerns

Trial design

22 participants in 1 patient group

study group

Description:

Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment

Treatment:

Device: RAPID