Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
研究概览
简要总结
The Dozee VS device developed by Turtle Shell Technologies Pvt. Ltd., is a contactless continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of Heart Rate (HR) and Respiratory Rate (RR). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters - Heart Rate (HR) and Respiratory Rate (RR) are generated. The captured vital parameters can be accessed remotely via a dashboard which can be accessed on any web browser and a smartphone application. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body. It consists of the following sub - units: Contactless sensor sheet, Dozee Pod with power cord, 5 Volt Universal Serial Bus (USB) Power Adapter, Health data compute server and Web Dashboard/Mobile App. This provides a more comfortable solution for long-term continuous patient monitoring. Continuous monitoring of people's vital signs, in particular Heart Rate (HR) and Respiratory Rate (RR), may provide a mechanism to alert doctors or nurses of clinical deterioration. Monitoring people's vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards.
详细描述
Dozee VS device is intended for the contactless continuous monitoring of vital parameters (Heart Rate and Respiratory Rate), and screening for abnormal changes in these parameters. The device is intended to be used to monitor individuals/patients greater than eighteen (18) years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs during sleep and resting state. The data can be viewed on the dashboard, exported and even be directly transferred to the in-house hospital management software. This protocol aims at verifying the safety and effectiveness of the investigational device in a general-care clinical environment. A similar predicate can be found in the FDA-cleared EarlySense 2.0 (K131379) developed by EarlySense Limited which shall be used as the predicate device. The device also uses the concept of ballistocardiography and employs piezoelectric sensors to create a contact-less continuous monitoring system which monitors the same vital parameters. It has been sold in over 20 hospitals in United Sates, since 2013, with no recalls or adverse events reported. According to publicly available clinical results, this system has shown an 86% reduction in Code Blue events, and a 45% reduction in Length of Stay (LoS) in the Intensive Care Unit (ICU) for patients coming from the medical/surgical unit. The technology employed and the indications for use for the EarlySense device is very similar to the Dozee VS device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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(Above 40 kgs)
- •Are located in a non-ICU hospital setting.
- •Agree to not eat during the testing period (2hours or 10 hours accordingly)
排除标准
- •Are connected to a device which 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
Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
时间窗: 12 Months
Record heart rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the investigational device and the gold standard device.
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
时间窗: 12 Months
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the investigational device and the gold standard device.
RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate
时间窗: 12 Months
Record heart rate in the predicate device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the predicate device and the gold standard device.
RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
时间窗: 12 Months
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the predicate device and the gold standard device.
次要结局
- Motion Notification Accuracy - Predicate (%)(12 months)
- Bed Exit Notification Accuracy - DUI (%)(12 months)
- Motion Notification Accuracy - Device Under Investigation (DUI) (%)(12 Months)
- Bed Exit Notification Accuracy - Predicate (%)(12 months)