Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

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.

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Key information

Conditions

Vital Signs Monitoring Physiologic Monitoring

Age range

0 day–12 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Respiratory Rate Accuracy

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

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.
Heart Rate Accuracy

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

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.

Secondary outcomes

Skin Tolerability

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

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.
Caregiver and Healthcare Provider Device Usability Perspective

Time frame: Immediately following completion of study participation.

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.
Respiratory Rate Average Root Mean Squared Error (ARMS)

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

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 contacts

Contact information is provided by the study sponsor or research team.

Alyssa Maximov, BSc.

CONTACT

[email protected]

5149341934 ext. 78229

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 31, 2026
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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