Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physiologic Monitoring; Vital Signs Monitoring
• Intervention / Treatment: Device: ANNE® Chest Sensor

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Alyssa Maximov, BSc.; Phone Number: 78229 5149341934; Email: alyssa.maximov@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
Infants; Hospitalized infants aged 29 days to <2 years admitted to the NICU or PICU	Device: 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.
Children; Hospitalized children aged 2 to <12 years admitted to the PICU	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Tolerability	Skin tolerability of the ANNE® Chest sensor, including the presence of erythema, irritation, or pressure marks following device use. Skin integrity will be assess by comparing before and after photos of sites of placement of wearable sensors using the Berger & Bowman Scoring Scale.	Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.
Caregiver and Healthcare Provider Device Usability Perspective	Caregiver and healthcare provider feedback regarding the usability and acceptability of the ANNE®. Parent and clinician perceptions will be assessed using a custom study questionnaire containing Likert-scale, multiple-choice, and open-ended questions addressing usability, comfort, perceived safety, perceived accuracy, and overall acceptability of the wireless monitoring system.	Immediately following completion of study participation.
Respiratory Rate Average Root Mean Squared Error (ARMS)	Average Root Mean Squared Error (ARMS) between respiratory rate measurements obtained from the ANNE® Chest sensor and the reference monitor within each age cohort.	Study monitoring period (4 to 8 hours per day over 2 consecutive days)

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Guilherme Sant'Anna, MD, PhD, RI-MUHC

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Infant; Neonate; Wearable sensors; Intensive care; Wireless monitoring; Physiologic monitoring
• Other Study ID Numbers: Wireless PICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes