Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

NCT07739823 | Not Yet Recruiting FDA Device

• 1 other identifier: Wireless PICU
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Keywords

Wireless monitoring; Wearable sensors; Pediatric; Neonate; Infant; Intensive care; Physiologic monitoring

Outcome Measures

Primary Outcomes (2)

• Respiratory Rate Accuracy

  Agreement between respiratory rate measured by the ANNE® Chest wireless sensor and the reference standard capnography. Accuracy will be evaluated using agreement analyses, with success defined as wearable-derived respiratory rate values within ±3 breaths per minute of the reference standard.

  Study monitoring period (4 to 8 hours per day over 2 consecutive days)

• Heart Rate Accuracy

  Agreement between heart rate measured by the ANNE® Chest wireless sensor and the reference standard bedside monitor. Accuracy will be evaluated using agreement analyses, with success defined as wearable-derived heart rate values within ±5 beats per minute of the reference monitor.

  Study monitoring period (4 to 8 hours per day over 2 consecutive days)

Secondary Outcomes (3)

• Skin Tolerability

  Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.

• Caregiver and Healthcare Provider Device Usability Perspective

  Immediately following completion of study participation.

• Respiratory Rate Average Root Mean Squared Error (ARMS)

  Study monitoring period (4 to 8 hours per day over 2 consecutive days)

Study Arms (3)

Neonates

Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU).

Device: ANNE® Chest Sensor

Infants

Hospitalized infants aged 29 days to \<2 years admitted to the NICU or PICU

Device: ANNE® Chest Sensor

Children

Hospitalized children aged 2 to \<12 years admitted to the PICU

Device: ANNE® Chest Sensor

Interventions

ANNE® Chest Sensor DEVICE

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.

Children; Infants; Neonates

Eligibility Criteria

• Age: 0 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized neonates, infants, and children (0 days to \<12 years of age) admitted to the NICU or PICU at the Montreal Children's Hospital who require continuous physiologic monitoring and whose parent or legal guardian provides informed consent.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Officials

• Guilherme Sant'Anna, MD, PhD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Maximov, BSc.

CONTACT

5149341934; alyssa.maximov@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share