An observational study in Vital Signs Monitoring and Physiologic Monitoring, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting. Open to participants aged 0 Days to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU).
Device: ANNE® Chest Sensor
Hospitalized infants aged 29 days to \<2 years admitted to the NICU or PICU
Device: ANNE® Chest Sensor
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.
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre