Clinical Research Directory
Browse clinical research sites, groups, and studies.
Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Summary
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the ANNE® Chest wireless wearable sensor for continuous monitoring of heart rate, respiratory rate, oxygen saturation, and skin temperature in hospitalized neonates, infants, and children (0 days to 12 years of age) in the neonatal and pediatric intensive care units (NICU and PICU). Measurements obtained from the wireless device will be compared with standard-of-care bedside monitoring and capnography. The study will also assess skin tolerability, signal reliability, and caregiver and healthcare provider perceptions of the device.
Official title: Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study
Key Details
Gender
All
Age Range
0 Days - 12 Years
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2026-09-01
Completion Date
2027-09-01
Last Updated
2026-07-31
Healthy Volunteers
No
Interventions
ANNE® Chest Sensor
Participants will wear the ANNE® Chest wireless skin-adherent physiologic sensor for continuous monitoring of heart rate, respiratory rate, electrocardiography (ECG), skin temperature, and body position during the study period. Measurements obtained from the investigational device will be compared with simultaneous standard-of-care bedside monitoring and capnography for validation purposes.