Physiologic Monitoring, Vital Signs Monitoring
Conditions
Keywords
Wireless monitoring, Wearable sensors, Pediatric, Neonate, Infant, Intensive care, Physiologic monitoring
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.
Interventions
DEVICEANNE® 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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Accuracy | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Skin Tolerability | 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 | 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) | 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. |
Contacts
CONTACTAlyssa Maximov, BSc.
PRINCIPAL_INVESTIGATORGuilherme Sant'Anna, MD, PhD
RI-MUHC
Outcome results
None listed