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.
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
CTAS 1
Skin conditions or isolation precautions preventing device placement
Implanted or adjacent devices that could interfere with sensors
Prior enrollment in the study
Parallel
wearable vital sign device
DeviceAbnormal 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.
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.
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.
Data completeness
Percentage of completed data in case report forms (CRFs)
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.
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.
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
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
