CTRI/2025/09/094627招募中不适用
Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits
Turtle Shell Technologies Pvt Ltd2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月12日
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
- 2
- 主要终点
- To evaluate whether the Dozee device meets the predefined product specifications for
研究概览
简要总结
The objective of the present study is to validate the updated (Gen 2) HR and RR algorithms of the Dozee system. The study will focus on evaluating algorithm performance in the
intended use population, including validation across the three sensor sheet variants—the DS, S1 and S1-I—to confirm that these meet the clinical claims and expectations..
研究设计
- 研究类型
- Observational
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
- •Agree to not eat during the testing period
- •Able to move and exit the bed independently and safely.
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 an ECG leads 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
To evaluate whether the Dozee device meets the predefined product specifications for
时间窗: At base line.
accuracy in measuring HR, RR, Motion and Bed-Exit.
时间窗: At base line.
次要结局
- To assess the agreement between Dozee and the gold standard reference(device using Bland-Altman analysis for HR and RR.)
- To evaluate the correlation between Dozee and the reference device using(Deming regression and Pearson’s correlation coefficient for HR and RR.)
- To determine the detection rate and range of HR and RR measured by(Dozee.)
- To benchmark the performance of the latest Dozee algorithm in comparison(with other versions through retrospective analysis using the collected BCG)
研究者
Dr Pradep Kumar Nagaraj
Kanva Sri Sai Hospital
研究点 (2)
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