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WIReD: Wireless Interstage Remote Device Study

NCT05975658 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2024-12-05

No results posted yet for this study

Summary

A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).

Conditions

  • Congenital Heart Disease in Children
  • Vital Signs
  • Pediatrics
  • Remote 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.

Sponsors & Collaborators

  • Gabi SmartCare

    collaborator INDUSTRY

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Lori Erickson, PhD · Director, Remote Health Solutions Children's Mercy

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-12-03
Completion
2024-12-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975658 on ClinicalTrials.gov