RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- RAPID imaging quality
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Deemed medically unstable by care team
- •Cardiology, ICU, hospitalist or bedside nurse concerns
Arms & Interventions
study group
Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment
Intervention: RAPID (Device)
Outcomes
Primary Outcomes
RAPID imaging quality
Time Frame: 30minutes
comparing the result of the data and imaging collected from the gold standard (PCU) vs the prototype device (RAPID) Two independent cardiologists will review each de-identified image in a large batch of standardized images consisting of random images from both RAPID and PCU. Each image will be reviewed by the cardiologists based on a specific checklist
Secondary Outcomes
No secondary outcomes reported