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The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study
Sponsor: Hamilton Health Sciences Corporation
Summary
This is a randomized, unblinded, single-centre, pilot feasibility study. A total of 100 patients will be enrolled and randomized to have their vital signs collected using either the Masimo Radius PPG and Radius T in combination with standard equipment, or only the standard equipment. Within the experimental group, Children will have their HR, RR, SpO2, and T measured using the wearable monitors, specifically the Masimo Radius PPG and Radius T devices that are attached to them wirelessly. Blood pressure (BP) will then be measured using standard equipment in the ED, after obtaining wireless vital signs. For the control group, Children will have their vital signs measured using standard hospital vital sign monitoring equipment. The project will be deemed successful if all primary feasibility thresholds are met and preliminary data show a trend toward reduced time-to-vitals and distress without safety concerns. Additional indicators include clear identification of logistical/training needs, dissemination of findings (peer-reviewed publication, PERC/TREKK networks), and a refined protocol for a definitive trial. Achieving these will demonstrate both proof-of-concept and readiness for multi-centre implementation.
Official title: The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Pilot Feasibility Study: Wearable Monitors for Autistic Children With Behavioural Challenges in Emergency Care
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09-01
Completion Date
2028-08-31
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
wearable vital sign device
Abnormal vitals resulting from environmental distress in autistic patients rather than underlying pathology may lead to unnecessary investigations, potential harm, or masking of underlying pathology. McMaster Children's Hospital (MCH) ED data over the past fiscal year highlights that one in five autistic children do not have T, HR or SpO2 readings duration their ED stay, whereas the standard is to have a full set of vitals at triage then every 2 hours while in the ED. Wearable monitors such as the Masimo Radius PPG and Radius T may address these challenges by enabling physical, contactless assessments, which will prevent repeated interruptions and unobtrusive monitoring. This pilot RCT will assess workflow integration, device tolerance, and data quality in the real-world context of pediatric emergency care for autistic children.