Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Sleep-wake state
研究概览
简要总结
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.
详细描述
The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to our hospital for the first time, with gestational age ≥28w;
- •Expected hospital stay ≥5 days.
排除标准
- •Apgar score ≤3 at 1 or 5 min after birth;
- •Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.
结局指标
主要结局
Sleep-wake state
时间窗: 10minutes after the meal, 5minutes each time, two times in total
Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Proportion of quiet sleep
时间窗: The hospital stay lasted 6 hours
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated.
Proportion of active sleep
时间窗: The hospital stay lasted 6 hours
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated.
Number of sleep cycles
时间窗: The hospital stay lasted 6 hours
The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
次要结局
- Respiratory rate(The hospital stay lasted 6 hours)
- Heart rate(The hospital stay lasted 6 hours)
研究者
Shujun Li
Honorary Director of Nursing Department
The Children's Hospital of Zhejiang University School of Medicine