The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously. Study objectives include: 1. Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU. 2. Assess safety of using a special wireless sensor system in neonates. 3. Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Infants admitted in the NICU are all subject to continuous monitoring of vital signs such as heart rate, respirations and oxygen saturation (SpO2) by placing sensors, leads, or bands directly on infant's skin and connecting them to monitors via wires. However, despite the rapid technological advances in wireless monitoring and wearable devices across various industries, the health care sector has traditionally lagged. Therefore, the investigators aim to explore the safety and effectiveness of wireless monitoring (ANNE™ Monitoring System) and compare it with the traditional wired monitoring system on infants with variable degrees of maturity in the NICU. More specifically, the investigators aim to examine (1) if it is feasible and to implement a wireless monitoring system in both term and preterm infants in the NICU; (2) if it is safe to use this particular wireless monitoring system among neonates; and (3) the accuracy of the wireless monitoring technology compared to the stand-of-care monitoring in the NICU.
Study Type
OBSERVATIONAL
Enrollment
75
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
Montreal Children's Hospital
Montreal, Quebec, Canada
Accuracy of wireless wearable heart rate data
Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable respiratory rate data
Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable skin temperature data
Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable oxygen saturation (SpO2) data
Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.
Time frame: 4 consecutive days of wireless monitoring
Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts
Proportion of monitoring time exhibiting unreliable wireless device signals due to significant movement artifacts. The exact definition of unreliable for each of the signals will be outlined before study initiation.
Time frame: 4 consecutive days of wireless monitoring
Proportion of time with loss of network connections or other technical problems
Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring.
Time frame: 4 consecutive days of wireless monitoring
Skin integrity at the sites of sensor placement
Skin integrity at the site of wireless lead placements from de-identified digital photographs, evaluated by a board-certified dermatologist who will evaluate for signs of irritation, redness and/or erosions.
Time frame: 4 consecutive days of wireless monitoring
Evaluation of potential subjective pain experienced by infant at time of sensor removal
Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal.
Time frame: 4 consecutive days of wireless monitoring
Clinicians', nursing, and parental perceptions
Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - electrocardiogram
Automated reports for electrocardiogram acquired from the wireless monitoring device
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - respiratory waveforms
Automated reports for respiratory waveforms acquired from the wireless monitoring device
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - oxygen saturation
Automated reports for oxygen saturation acquired from the wireless monitoring device
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - temperature
Automated reports for temperature acquired from the wireless monitoring device
Time frame: 4 consecutive days of wireless monitoring
Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device
For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with RIP (the gold standard) with the simultaneously recorded wireless monitoring device data.
Time frame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Enhanced respiratory monitoring using accelerometry
For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with thoracic impedance (the current standard) with the simultaneously recorded wireless monitoring device data.
Time frame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
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