The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Accuracy of wireless wearable skin temperature data
研究概览
简要总结
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:
- Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU.
- Assess safety of using a special wireless sensor system in neonates.
- Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Hours 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants in room air at enrollment
- •Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment
- •Healthy preterm infants in room air at enrollment
- •Preterm infants on continuous positive airway pressure at enrollment
- •Preterm infants on conventional mechanical ventilation at enrollment
- •Preterm infants on high frequency ventilation at enrollment
- •Preterm infants on nasal intermittent positive end expiratory pressure at enrollment
- •Preterm infants on continuous positive airway pressure at enrollment
排除标准
- •Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia)
- •Congenital heart disorders
- •Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
结局指标
主要结局
Accuracy of wireless wearable skin temperature data
时间窗: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable heart rate data
时间窗: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable respiratory rate data
时间窗: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.
Clinicians', nursing, and parental perceptions
时间窗: 4 consecutive days of wireless monitoring
Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.
Accuracy of wireless wearable oxygen saturation (SpO2) data
时间窗: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.
Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts
时间窗: 4 consecutive days of wireless monitoring
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.
Skin integrity at the sites of sensor placement
时间窗: 4 consecutive days of wireless monitoring
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.
Proportion of time with loss of network connections or other technical problems
时间窗: 4 consecutive days of wireless monitoring
Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring.
Evaluation of potential subjective pain experienced by infant at time of sensor removal
时间窗: 4 consecutive days of wireless monitoring
Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal.
次要结局
- Automated reports of physiological health - oxygen saturation(4 consecutive days of wireless monitoring)
- Enhanced respiratory monitoring using accelerometry(2 to 3 consecutive hours each day during the 4-day continuous monitoring)
- Automated reports of physiological health - temperature(4 consecutive days of wireless monitoring)
- Automated reports of physiological health - electrocardiogram(4 consecutive days of wireless monitoring)
- Automated reports of physiological health - respiratory waveforms(4 consecutive days of wireless monitoring)
- Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device(2 to 3 consecutive hours each day during the 4-day continuous monitoring)
研究者
Guilherme Sant'Anna, MD
Professor of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre