Evaluation of the Accuracy and Reliability of the Dozee System for Vital Sign Monitoring in Diverse Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- 1. Mean absolute Error (MAE) of Dozee’s vitals parameters, HR, HRV, RR, BP, Temperature and SpO2 in comparison with the gold standard and or
研究概览
简要总结
This study is to validate the accuracy and reliability of the Dozee system in measuring vital parameters, including heart rate (HR), heart rate variability (HRV), respiratory rate (RR), temperature, oxygen saturation (SpO2), blood pressure (BP), heart rhythm, posture, and motion (movement accuracy and bed exit accuracy). This validation will be achieved by comparing the measurements obtained from the Dozee system to those from gold standard devices, equivalent devices operating on similar principles, and manual observations under diverse environmental and subject-specific conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting adults 18 years old ICU patients
- •Weight between 40kg-120kgs
- •They are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent.
排除标准
- •Weight below 40 kgs and above 120 kgs
- •Currently pregnant
- •Exhibit injuries, deformities, or other abnormalities that, in the opinion of the investigator, may prevent proper placement of accessories
- •Level of agitation or non-compliance too high to enroll
- •Needs the use of equipments whose operation can interfere with Dozee’s signal
- •A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures.
结局指标
主要结局
1. Mean absolute Error (MAE) of Dozee’s vitals parameters, HR, HRV, RR, BP, Temperature and SpO2 in comparison with the gold standard and or
时间窗: Baseline
equivalent devices
时间窗: Baseline
2. Motion Notification Accuracy (%), Bed Exit Notification Accuracy and Posture Accuracy (%) of the Dozee in comparison with equivalent devices
时间窗: Baseline
and manual observations.
时间窗: Baseline
3. Dozee’s sensitivity in the detection of heart rhythms in comparison with the
时间窗: Baseline
gold standard method.
时间窗: Baseline
次要结局
- Dozees detection rate and or detection range of HR HRV RR BP SpO2 cardiac rhythms in comparison to the gold standard and or equivalent devices(Baseline)
研究者
Dr Kumar Chokalingam
Turtle Shell Technologies Pvt Ltd