Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- SpO2
研究概览
简要总结
Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission.
The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU patients.
This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the Philips monitoring system.
The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.
详细描述
Introduction:
Patients readmission to PICU is a major point of concern for physician because, although being a rare event, it has been strongly associated to more morbidity and death. Patients monitoring once they have left the PICU is drastically modified and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the monitoring of adults but they do not exist for children.
Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.
Main objective:
Assess the accuracy of VT-Patch to measure oxygen saturation (SpO2) in children with diverse skin colour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.
- •PICU monitoring for the next 24 hours
排除标准
- •Recent cardiac or thoracic surgery
- •Thoracic skin lesion that contraindicates the VT-Patch
- •No parental consent
- •Intermittent presence of one study observer in the patient room is considered inappropriate by the physician or the nurse in charge because of the child's medical condition
结局指标
主要结局
SpO2
时间窗: 8 hours
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care
SpO2
时间窗: 8 hours
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care
次要结局
- Heart rate(8 hours)
- Respiratory rate(8 hours)
- Temperature(8hours)
研究者
Philippe Jouvet
Professor
St. Justine's Hospital