Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

Qualifiers

Neonates (0-28 days of life)

Infants (29 days of life - 2 years, i.e., not turned 2 years old)

Children (2 years old - 12 years old, i.e., not turned 12 years old)

Disqualifiers

Contraindication to application of skin sensors (e.g., rash, surgical site, skin breakdown, open wounds, burns, active dermatitis, etc.) at the application site.

Severe hemodynamic instability requiring escalating interventions.

Congenital airway abnormalities interfere with accurate capnography.

Diagnosed neuromuscular disorders affecting respiratory mechanics.

Trial design

Treatments tested in this trial

  • ANNE® Chest Sensor

Treatment groups

42 Participants
are divided into 3 treatment groups

Locations

This trial has no locations