WIReD: Wireless Interstage Remote Device Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After enrollment, parents will be taught by the study team on the use of the Pediarity System which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor application for data transfer. This education by the study team will ensure uniform training and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi monitoring application. Parents can ask the study team any use and/or technical questions during this time period. All clinical care questions from standard of care monitoring will go to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the Pediarity System - they will be referred to use their standard of care pulse oximetry before any clinical intervention and care is recommended by the healthcare team. The study team will not make any healthcare or diagnostic recommendations during the monitoring period based on any Pediarity System data.

The study team will educate parents and LARs on the Pediarity System. This system does not replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place the Gabi band on their child and use the Pediarity System at any frequency they choose in the home setting for a length of approximately one month at home (to coordinate when they return to the study site for a care visit). Parents can email or Teams call the study team directly (during daytime hours M-F) for any technical questions during this the study period. The study team will evaluate clinical data only at the conclusion of the study period and qualitative feedback from the parents will be gathered.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease in Children Vital Signs Pediatrics Remote Monitoring

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pediatric Physiologic vital signs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lori Erickson

Director, Remote Health Solutions

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lori Erickson, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Remote Health Solutions Children's Mercy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00002554

Identifier Type: -

Identifier Source: org_study_id