The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Pilot Feasibility Study: Wearable Monitors for Autistic Children With Behavioural Challenges in Emergency Care

1.0 WHAT IS THE PROBLEM TO BE ADDRESSED? Children with Autism Spectrum Disorder (ASD) are significantly overrepresented in Emergency Department (ED) visits, with higher rates of behavioural crises, sensory dysregulation, and unmet medical needs compared to their neurotypical peers.3,4 These children often encounter environments with bright lights, loud noises, unpredictable routines, and unfamiliar staff which can exacerbate distress, complicate assessment, and prolong care.5 Routine vital sign collection is frequently incomplete and a source of distress in autistic patients. 6 Routine collection instruments such as fingertip pulse oximeters and contact thermometers require repeated touch by unfamiliar providers, often in an overstimulating triage room. 7,8 For autistic patients with sensory or communication challenges, these situations may cause distress and escalate to repeated vital sign attempts, delayed decision-making, physical or chemical restraints, interventions with known physical and emotional risks, and moral distress for the patients, families, and healthcare providers involved.9 While sensory toolkits or environmental adaptations can help reduce discomfort, they do not solve the problem of standard vital sign machines capturing limited or unreliable data that is crucial for patient care, when collected during a time of exacerbated distress.5 Wearable biometric monitoring devices such as the Masimo Radius PPG and Radius T offer a promising alternative. This device is being utilized at Dartmouth General Hospital in Nova Scotia to better manage ED wait times and continuously monitor high-risk patients, but no hospital has assessed the benefits it may have on supporting pediatric patients with ASD.30 These devices use a lightweight adhesive sensor that can be applied quickly with the support of caregivers anywhere in the ED. Once applied, they wirelessly measure heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2) and temperature (T), allowing the child and caregiver to move to a quieter, less stimulating environment while accurate vitals are collected. This could reduce distress for the patient and their caregiver(s), improve vital sign data collection, and support trauma-informed, neuro-affirming care. 10,11,12,13,14 Independent studies have demonstrated Radius PPG utility for continuous monitoring in perioperative, acute, and chronic care contexts, however their feasibility and acceptability in a high-acuity pediatric ED setting, particularly for autistic children, remain untested.

1.1 WHAT ARE THE RESEARCH QUESTION(S) TO BE ADDRESSED?

Among autistic children aged 2-17 years presenting to the ED, does the combined use of Masimo Radius PPG and Radius T wearable monitors reduce the time required to obtain HR, RR, SpO2 and T by at least 20% compared to standard methods, without increasing distress levels, as measured by two objective, validated, behavioural scales revised Faces, Legs, Activity, Cry, Consolability (r-FLACC) and Children's Fear Scale (CFS). Before we can answer this question, several uncertainties remain regarding feasibility, tolerance, and data completeness. To address these gaps, we propose a pilot feasibility trial with the following aims:

Primary aim: To determine the feasibility of conducting a definitive multicentre randomized controlled trial comparing wearable monitoring with standard-of-care vital-sign monitoring in autistic children presenting to a pediatric emergency department. Primary trial feasibility will be assessed using participant retention, protocol adherence, and completeness of required study data.

Primary hypothesis: