Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient | NCT07739823

NCT07739823

Overview

NCT ID: NCT07739823
Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
Official Title: Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study
Brief 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.
Conditions: Vital Signs Monitoring
Physiologic Monitoring

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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.

Known adhesive allergies.

Inability to tolerate device placement due to behavioral issues.

Participation in conflicting clinical trials.

High-frequency oscillatory or mechanical ventilation.

Active bronchiolitis with mask intolerance.

Recent facial surgery preventing EtCO₂ nasal line placement.

Behavioral conditions preventing adherence to device wearing.

Central Contacts: Alyssa Maximov, BSc.Contact
alyssa.maximov@muhc.mcgill.ca5149341934 ext. 78229