Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)

Sponsor

Gabi SmartCare (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05319236

Collaborator

(none)

100

Enrollment

Locations

Arm

7.4

Anticipated Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.

The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children < 6 years old with underlying medical conditions.

This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system.

The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers.

*During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease Respiratory Disease Congenital Cardiac Defect Cardiovascular Diseases Chronic Respiratory Disease Chronic Cardiopulmonary Disease Premature Infant Disease	Device: Gabi System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Prospective, Multicentric Interventional Study Assessing the Range of Most Clinically Relevant Indications for Use of the Non-invasive Wireless Gabi System for the Recording, in Non-motion Condition, of SpO2, Pulse Rate, Respiratory Rate and Movements of Young Children With Underlying Medical Conditions.

Actual Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Gabi System Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.	Device: Gabi System See arm description

Arm

Intervention/Treatment

Other: Gabi System

Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.

Device: Gabi System

See arm description

Outcome Measures

Primary Outcome Measures

Clinical Utility [Assessed at the end of the 3-month period for each participant]
Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.
Caregiver Usability [Assessed at the end of the 3-month period for each participant]
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
HCP Usability [Assessed at the end of the 3-month period for each participant]
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Infants and children < 6 years old.
Subjects who present at least one of the following underlying medical conditions:
Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently and could benefit from an additional post-surgery monitoring at home, per the investigator's opinion.
Subjects at risk awaiting surgery.
Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy.
Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia.
Subjects with chronic respiratory disease, such as asthma, developmental or cardiovascular conditions who could benefit from medical monitoring at home, per the investigator's opinion.
Subjects with chronic respiratory support at home.
Premature babies who required intensive neonatal care.
Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks.
A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject
Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study.
Signed informed consent form prior to performing any study specific procedure.
Willing and likely (based on the investigator's judgement) to comply with all study requirements.

Exclusion Criteria:

Weight < 2.5 kg.
Subject presenting an anatomical limitation that would prevent the use of the Gabi system.
Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ).
Subjects participating in another interventional clinical study (with the exception of registries), which may have an impact on this study outcomes, based on the investigator's judgement.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's National Hospital	Washington	District of Columbia	United States	20010
2	Columbia University Irving Medical Center	New York	New York	United States	10032
3	Universitair Ziekenhuis Antwerpen (UZA)	Antwerp		Belgium	2610
4	Clinique CHC Montlégia	Liège		Belgium