The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study (BRAVE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: wearable vital sign device

Detailed Description

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:

A definitive multicentre trial will be considered feasible if the prespecified Green RAG progression thresholds are met for participant retention, protocol adherence, and completeness of required study data, with each primary trial-feasibility outcome reaching at least 80% and with no safety concern requiring study discontinuation.

Secondary intervention-feasibility aim: To describe the feasibility of delivering each allocated monitoring approach, including successful initiation of the assigned approach, participant tolerance, successful acquisition of each clinically indicated vital sign, and the reasons for any unsuccessful initiation, discontinuation, or measurement. These outcomes will be reported descriptively and will not determine RAG progression to a definitive trial.

Secondary aim: To identify the most appropriate primary outcome for the definitive trial using the following hierarchy: (1) caregiver and participant preference (time of completion, r-FLACC and CFS, or composite outcome) and (2) data quality and fullness of time of completion and r-FLACC and CFS (≥80% completeness without errors).

Secondary hypothesis: We hypothesize that caregivers and participants will prioritize the composite outcome (time completion without increase in distress) 2.0 WHY IS THE TRIAL NEEDED NOW? Autistic children face many systemic barriers to receiving timely, accessible, and proper neurodiversity-affirming care within the ED .9,17,18,32 Common obstacles encountered by children with ASD and their families include: a shortage of ASD specialists and resources especially within rural communities, lack of clinical knowledge and training, inaccurate diagnoses, and societal stigma.31. Distress frequently leads to abnormal vital signs, particularly HR and RR, which are also critical indicators of severe disease (e.g. sepsis) and essential for reliable clinical assessment. 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. 17,18 Local 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. There is a clear need for complete, timely and comfortable vital sign collection for this underserved group, leading to better care experiences for patients, caregivers, and clinicians.

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.

This study targets intersecting priorities in pediatric emergency medicine, health equity, and digital innovation. No direct benefit to individual participants is guaranteed. If wearable monitoring proves feasible, acceptable, and safe, potential future benefits include: (1) improving the experience, safety, and dignity of future patients by reducing distress and reliance on coercive interventions;19 (2) supporting timely clinical decision-making and efficient resource use through more reliable vital-sign acquisition; (3) advancing health equity for a population that faces systemic barriers to humane, effective care; (4) identifying logistical and training needs; and (5) informing a future multicentre trial through PERC.

A comprehensive search of ClinicalTrials.gov revealed no registered trials, and a literature review conducted during trial preparation found no reports of wearable-device use in this population, underscoring the novelty of the approach.20,21,22,23 The trial will be registered on ClinicalTrials.gov before recruitment or enrollment of the first participant, and the registration number will be provided to HiREB through the Correspondence feature in eREB before recruitment begins. Innovations include technology repurposed for autistic children; integration of patient-centred outcomes such as speed, behavioural distress, and acceptability;24 an implementation-oriented design with scale-up plans through PERC; and an equity focus aligned with patient and caregiver priorities.25 The co-chair of the MCH Family Advisory Council and a caregiver of an autistic child helped shape the trial and will continue to provide structured input, including review of patient-facing materials. Findings will inform a future multicentre trial and sensory-friendly ED protocols.

If wearable monitors prove faster, accurate, and well-tolerated for autistic children, they could significantly improve pediatric ED care. Faster vital sign collection enables earlier clinical decision-making, reduces overall visit times, and prevents repeated attempts that distress children and delay care. Reduced distress can improve cooperation, lower the risk of escalating behaviors, and create a calmer environment for families and staff. For clinicians, streamlined monitoring could improve workflow efficiency, make nurses available to conduct their other responsibilities, improve evaluation accuracy, and reduce interruptions to other critical tasks. At the healthcare system level, these benefits could translate into better patient fewer resource-intensive encounters, and improved satisfaction scores. Adoption of wearable technology could also benefit other populations who have difficulty with traditional monitoring, expanding the impact to other neurodiverse children and the broader pediatric and adult care settings.

3.0 HOW WILL THE RESULTS OF THIS TRIAL BE USED? We expect this pilot trial to demonstrate that a definitive multi-centre trial is feasible, meeting our predefined progression thresholds. We anticipate that caregivers and participants will identify the composite outcome of timely completion of vital signs without moderate or severe distress as the most meaningful measure, and that this outcome will be feasible and reliable to collect. We anticipate that wearable monitoring can shorten the time needed to obtain vital signs without increasing distress and will be rated as acceptable by caregivers and staff. These outcomes will confirm feasibility, guide the choice of the primary outcome, and provide critical data to inform the design and sample size of the future definitive trial.

4.0 ANTICIPATED RISKS AND MITIGATION Anticipated operational and study-related risks include recruitment shortfalls, protocol adherence below progression thresholds, poor participant tolerance of the assigned monitoring approach, unsuccessful acquisition of one or more clinically indicated vital signs, incomplete study-data collection, device malfunction or connectivity failure, contamination, and data-capture failure. Application or continued wearing of the wearable sensors may cause transient discomfort or distress and may result in skin irritation or injury.

Behavioural escalation may occur during routine emergency care. In some circumstances, the treating clinical team may independently determine that physical restraint or sedation is clinically necessary to obtain essential assessments or provide treatment. These decisions will be based solely on the participant's clinical needs, will remain entirely at the discretion of the treating clinical team, and will not be directed by the research team. Physical restraint or sedation will not be used to initiate, continue, or complete any research procedure.

Mitigation strategies include a sensory-adapted monitoring pathway, a two-stage informed consent process, standardized application procedures, caregiver involvement, developmentally appropriate communication, individualized behavioural supports, immediate discontinuation of research-specific procedures if significant distress or refusal occurs, real-time REDCap timestamps with weekly audits, training of delegated research personnel, backup device inventory, and paper CRF backups.

A RAG dashboard for the three primary trial-feasibility outcomes-participant retention, protocol adherence, and completeness of required study data-will be reviewed weekly. Prespecified corrective actions will be implemented for Amber performance. Red feasibility performance will trigger formal review and potential study redesign. The study will be paused if a prespecified safety stopping rule is met or another safety concern requires formal review.

Privacy safeguards will comply with the Personal Health Information Protection Act (PHIPA), including role-based REDCap access, secure institutional storage of identifiable information, and restricted access to study records. The REDCap database will be hosted by the Population Health Research Institute. Wearable monitoring devices used in this study will not transmit identifiable participant information to Masimo, other external vendors, or external cloud-based systems. Study records may be reviewed by authorized study personnel and, where required for monitoring, auditing, or regulatory oversight, by HiREB, authorized Hamilton Health Sciences institutional monitors, and applicable regulatory authorities.

If a participant demonstrates significant distress, refuses, or is unable to tolerate the assigned monitoring approach, research-specific procedures will stop. The treating clinical team will determine how clinically indicated vital signs should be obtained using the usual clinical approach, independently of study participation. Decisions regarding behavioural support, timing of assessment, restraint, sedation, or other clinical interventions will remain entirely at the discretion of the treating clinical team. The outcome of the assigned monitoring attempt and the reason for discontinuation will be recorded as intervention-feasibility outcomes, where applicable.

The Masimo Radius PPG is contraindicated in patients with known allergic reactions or hypersensitivity to foam rubber products, adhesive tape, or components of the device adhesive. The sensor site will be assessed according to the manufacturer's instructions and routine clinical practice to ensure adequate adhesion, circulation, and skin integrity. Participants with skin conditions, compromised skin integrity, or other circumstances preventing safe device placement will not undergo wearable-device application.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: April J Kam, MD MScPH FRCPC; Phone Number: 76038 905-521-2100; Email: kama@mcmaster.ca
• Study Contact Backup: Name: Redjana Carciumaru, MSc, MD; Phone Number: 73864 905-521-2100; Email: carciur@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 2 to 17 years
2. Suspected or confirmed ASD diagnosis by chart or caregiver
3. Presenting to ED visit and requiring vital signs
4. Anatomically suitable sites for device placement
5. Participant with capacity (including a mature minor) or caregiver/substitute decision-maker able to complete the informed consent process in English. Certified interpreters will not be used to translate the research consent process in this pilot because validated translated consent documents are unavailable.
6. Ability to observe the child for at least 30 minutes to measure time-to-vitals and r-FLACC and CFS scores

Exclusion Criteria:

1. CTAS 1
2. Skin conditions or isolation precautions preventing device placement
3. Implanted or adjacent devices that could interfere with sensors
4. Prior enrollment in the study
5. Known allergy or hypersensitivity to foam rubber, adhesive tape, or device adhesive components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable Device; 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.	Device: 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.
No Intervention: Standard of care; Children will have their vital signs measured using standard hospital vital sign monitoring equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Proportion of randomized participants for whom the assigned monitoring approach is initiated or attempted in accordance with the protocol, with the outcome of the attempt and any reason for non-initiation or discontinuation documented. Unsuccessful acquisition of a vital sign following an appropriate attempt will not be classified as protocol non-adherence.	Through study completion, an average of 1 day
Retention	Proportion of randomized participants who remain enrolled through completion or discontinuation of the assigned monitoring attempt and permit retention of study data collected up to that point. Participants whose monitoring attempt is discontinued because of behavioural intolerance, clinical decision-making, or technical failure will not be classified as failures of retention.	From baseline assessment to the final intervention assessment, up to 40 minutes
Data completeness	Percentage of completed data in case report forms (CRFs)	From enrollment to post-assessment survey, caregiver acceptability assessed using structured LIKERT scale, questionnaire through study completion, an average of 1 Day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce time-to-complete for heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2) and temperature (T)	Measurement: Time from first contact with the assigned device or equipment to successful recording of all allocated heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2) and temperature (T) measurements. Participants whose attempt ends without completion will be censored at the end of the attempt or last observation; results will be analyzed using Kaplan-Meier methods. Success criterion: Shorter median time in wearable arm without safety events.	Time from first intervention assessment to the last intervention assessment up to 30 minutes
Reduce behavioural distress during vital sign collection	Measurement: revised Faces, Legs, Activity, Cry, Consolability (r-FLACC, 0-10 score: mild distress (0-3); moderate distress (4-6); and severe distress (7-10)). Total scores at baseline and then three other timepoints during monitoring by trained research personnel. Success criterion: Lower mean distress score change in wearable arm. Use of restraint or sedation during the ED encounter: The occurrence of physical restraint or sedation/chemical restraint will be recorded in both study arms as an exploratory clinical and balancing outcome. The treating clinician's documented indication, timing relative to the assigned monitoring attempt, and relationship to routine clinical care will be recorded. These events will not automatically be classified as research-related adverse events.	Total scores from baseline assessment to the final intervention assessment, up to 40 minutes
High acceptability to caregivers and staff	Measurement: Structured Likert-scale (1-strongly disagree, 2-disagree, 3-neutral, 4-agree, 5-strongly agree) surveys post-monitoring. Success criterion: ≥75% rate devices as "comfortable" and "easy to use," and would choose them again. Recruitment. Total score	From enrollment up to 1 Day
Recruitment/consent feasibility	Measurement: Proportion of eligible participants who provide consent, with 95% confidence intervals. Success criterion: Planning benchmark: The consent rate will be reported descriptively with a 95% confidence interval. A consent rate of at least 70% is considered desirable for planning a future multicentre study but will not determine RAG progression.	from approach of introductory consent process until informed signed consent granted or denied, up 1 Day
Intervention Feasibility	Measurement: Proportion of participants in whom the allocated monitoring approach is initiated, tolerated, and results in successful acquisition of each clinically indicated vital sign. Analysis: Descriptive proportions with 95% confidence intervals. Rationale: To inform the practicality and implementation of the intervention for a future definitive multicentre RCT.	From enrollment to post-assessment or discharge, up to 1 Day
Reduce behavioural distress during vital sign collection	Measurement: Children's Fear Scale (CFS: not anxious (Face A); a little anxious (Face B); moderately anxious (Face C); very anxious (Face D); and extremely anxious (Face E). Total scores at baseline and then three other timepoints during monitoring by trained research personnel. Success criterion: Lower mean distress score change in wearable arm. Use of restraint or sedation during the ED encounter: The occurrence of physical restraint or sedation/chemical restraint will be recorded in both study arms as an exploratory clinical and balancing outcome. The treating clinician's documented indication, timing relative to the assigned monitoring attempt, and relationship to routine clinical care will be recorded. These events will not automatically be classified as research-related adverse events.	Total scores from baseline assessment to the final intervention assessment, up to 40 minutes

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: HAH - 26 - 009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No