WIReD: Wireless Interstage Remote Device Study

NCT05975658 | Completed

• 1 other identifier: STUDY00002554
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric; Physiologic vital signs

Outcome Measures

Primary Outcomes (1)

• Parental Experience Evaluation

  Rigorously explore the parental experience of utilizing a continuous pediatric wireless device for monitoring at home pulse oximetry compared with standard of care periodic pulse oximetry through parent interviews.

  3-6 Weeks

Secondary Outcomes (11)

• Data Transfer Rate Evaluation

  3-6 Weeks

• Stakeholder Experience Assessment

  3-6 Weeks

• Data Threshold Event Rate Evaluation

  3-6 Weeks

• Satisfaction with the System

  3-6 weeks

• Effectiveness with the System

  3-6 weeks

Interventions

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

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.

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Maximum of 15 infants in the congenital, arrhythmic, or acquired heart disease population to be enrolled at Children's Mercy Hospital Kansas City.

You may qualify if:

• Study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy Kansas City.
• Age criteria for children: after birth and who are less than two years of age at the time of being approached.
• The child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the CHAMP application in the home setting.
• CHAMP App CM IRB 15030113 - Pediatric patients may be followed by the CHAMP Clinical team or enrolled in the CHAMP App Cardiac Study

You may not qualify if:

• Over two years of age at the time of being approached for study participation.
• Families that do not speak English or Spanish (languages supported by the devices).
• Families that do not have access to a Wi-Fi network at home.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Gabi SmartCare: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Links

• Gabi SmartCare Website

Study Officials

• Lori Erickson, PhD

  Director, Remote Health Solutions Children's Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Remote Health Solutions

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: September 30, 2023
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)