WIReD: Wireless Interstage Remote Device Study

CompletedOBSERVATIONAL
Enrollment

13

Participants

Timeline

Start Date

September 30, 2023

Primary Completion Date

December 3, 2024

Study Completion Date

December 3, 2024

Conditions
Congenital Heart Disease in ChildrenVital SignsPediatricsRemote Monitoring
Interventions
DEVICE

Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]

Gabi SmartCare has created a monitoring system named Pediarity System that obtains pediatric vitals data through non-invasive means through a Gabi band. When paired with a proprietary algorithm and software - Gabi Analytics - the cloud-based platform measures blood oxygen levels, pulse rate (and variability), respiratory rate, actigraphy, inter-beat interval, and tracking for the time the device is worn (or not worn by the child). Three LEDs on the monitor are used for capturing this information. Peak wavelengths for the red, infrared, and green LEDs operate at 660nm, 950nm, and 526nm respectively. The Gabi band features an optical front end coupled with an analog front end using 24 bits. Bluetooth data transmission is utilized on a mobile phone application with a tablet-based system in a CSV format for the purpose of offline data processing.

Trial Locations (1)

64108

Children's Mercy Hospital, Kansas City

All Listed Sponsors
collaborator

Gabi SmartCare

INDUSTRY

lead

Children's Mercy Hospital Kansas City

OTHER

NCT05975658 - WIReD: Wireless Interstage Remote Device Study | Biotech Hunter | Biotech Hunter