Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.
研究概览
简要总结
The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring
- •undergoing monitoring with the INVOS wired NIRS system.
排除标准
- •Infants with a skin abnormality that would potentially increase the risk of injury,
- •Patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.
结局指标
主要结局
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.
时间窗: 6 months
Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.
次要结局
- Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).(6 months)
- Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).(6 months)
- Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device.(6 months)
研究者
Guilherme Sant'Anna, MD
Neonatologist
McGill University Health Centre/Research Institute of the McGill University Health Centre