Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds

Conditions
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No Specific Medical Conditions or Disease States

Intervention / Treatment
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* Device: Telemetry monitoring
* Device: Continuous monitoring through Earlysense
* Device: Continuous monitoring through Dozee VS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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. Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm Study (Cohort)<br>All participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively). In addition, two contactless monitoring devices will be placed on the patient bed to measure data. These devices include EarlySense (USFDA approved ballistocardiography device) and Dozee VS (Investigational Device). Data from all devices will be measured simultaneously. | Device: Telemetry monitoring<br>* All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).<br>Device: Continuous monitoring through Earlysense<br>* EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements<br>Device: Continuous monitoring through Dozee VS<br>* Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate | 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. | 12 Months | 
| RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate | 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. | 12 Months | 
| RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate | 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. | 12 Months | 
| RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate | 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. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Notification Accuracy - Device Under Investigation (DUI) (%) | Record the time for each instructed movements from manual observation and time for movements notification recorded in the investigational device. Calculate the times matched between these two to get the accuracy. | 12 Months | 
| Bed Exit Notification Accuracy - DUI (%) | Record the time for each instructed bed exit from manual observation and time for bed exit notification recorded in the investigational device. Calculate the times matched between these two to get the accuracy. | 12 months | 
| Motion Notification Accuracy - Predicate (%) | Record the time for each instructed movements from manual observation and time for movements notification recorded in the predicate device. Calculate the times matched between these two to get the accuracy. | 12 months | 
| Bed Exit Notification Accuracy - Predicate (%) | Record the time for each instructed bed exit from manual observation and time for bed exit notification recorded in the predicate device. Calculate the times matched between these two to get the accuracy. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Monitoring, Ballistocardiography, HR, RR, Dozee VS