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 Type
OBSERVATIONAL
Enrollment
42
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.
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.
Time frame: 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.
Time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
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.
Time frame: 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.
Time frame: 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.
Time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
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