Congenital Heart Disease
Conditions
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.
Interventions
DEVICERAPID
test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RAPID imaging quality | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGwenyth Fischer, MD
University of Minnesota
Outcome results
None listed