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

NCT07828964 | Not Yet Recruiting

• 1 other identifier: HAH - 26 - 009
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Reduce time-to-complete for heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2) and temperature (T)

  Time from first intervention assessment to the last intervention assessment up to 30 minutes

• Reduce behavioural distress during vital sign collection

  Total scores from baseline assessment to the final intervention assessment, up to 40 minutes

• High acceptability to caregivers and staff

  From enrollment up to 1 Day

• Recruitment/consent feasibility

  from approach of introductory consent process until informed signed consent granted or denied, up 1 Day

• Intervention Feasibility

  From enrollment to post-assessment or discharge, up to 1 Day

Study Arms (2)

Wearable Device

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

Children will have their vital signs measured using standard hospital vital sign monitoring equipment.

Interventions

wearable vital sign device 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.

Wearable Device

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2 to 17 years
• Suspected or confirmed ASD diagnosis by chart or caregiver
• Presenting to ED visit and requiring vital signs
• Anatomically suitable sites for device placement
• 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.
• Ability to observe the child for at least 30 minutes to measure time-to-vitals and r-FLACC and CFS scores

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

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MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

April J Kam, MD MScPH FRCPC

CONTACT

905-521-2100; kama@mcmaster.ca

Redjana Carciumaru, MSc, MD

CONTACT

905-521-2100; carciur@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Control group: Children will have their vital signs measured using standard hospital vital sign monitoring equipment. A study statistician will generate the randomization schedule using variable permuted block sizes. This schedule will be securely imported into an Excel file for the data management team to create 100 randomization envelopes. Only the research personnel will have access to the envelopes. At triage, after eligibility is confirmed and verbal consent is obtained, research personnel will open the next sequential envelope to reveal the allocation, in which trained personnel will apply either the wearable device or standard hospital vital sign monitor.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-07