Validation of continuous monitoring of body vitals by Dozee
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Mean Absolute Error of Dozee’s Heart Rate and Gold Standard Devices heart rate
研究概览
简要总结
The present study aims to:
1. Validate Dozee HR and RR considering Patient Monitoras gold standard.
2. Verify the EarlySense System HR and RRconsidering Patient Monitor as gold standard.
3. The study separately intended to show anon-inferiority trial of the Investigational device with the Predictive devicei.e EarlySense System.
Dozee device developedby Turtle Shell Technologies Pvt. Ltd., is intended for contactless continuousmonitoring of vital parameters (HR and RR), and screening for abnormal changesin these parameters. The device uses the concept of ballistocardiography anddeploys piezoelectric sensors to capture the micro-vibrations originating fromcardiac contractions, upper respiratory tract activity and body movements. Thisdata is then analyzed by a proprietary algorithm and the values of the vitalparameters are generated. The device is intended to be used to monitorindividuals/patients greater than eighteen years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signsduring sleep and resting state. The setup includes placing a sensor under themattress, and a bedside unit on a nearby flat surface. The other components ofthe setup are Power cords and Power adapter. Thus, a power outlet withsufficient plug sockets near the bed will be required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults Male or female.
- •(Above 18 years of age)
- •Provide written informed consent.
- •Weight between 40kg/88.18lbs and 120kg/264.55lbs
- •Are stable ICU patients or patients admitted in wards.
排除标准
- •Are connected to a device that may interfere with the device monitoring in this study.
- •Are receiving any bedside care which may be incompatible with the study procedures.
- •A likely need to receive or undergo a procedure during the testing period.
- •Cannot accept a nasal cannula or have a monitor lead placed on the chest.
- •Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
结局指标
主要结局
1. Mean Absolute Error of Dozee’s Heart Rate and Gold Standard Devices heart rate
时间窗: At Baseline at the time of patient enrolment into the study
2. Mean Absolute Error of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate
时间窗: At Baseline at the time of patient enrolment into the study
次要结局
- 1. Root Mean Square Difference of Dozee’s Heart Rate and Gold Standard Devices heart rate(2. Root Mean Square Difference of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate)