Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS
Condition: No Specific Medical Conditions or Disease States
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): Telemetry monitoring; Continuous monitoring through Earlysense; Continuous monitoring through Dozee VS
Intervention type(s): Device; Device; Device
Intervention description(s): All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).; EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements; Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be conducted on 105 subjects in the age group above 18 years regardless of
        gender. The patients admitted in the hospital will be informed about the study and a
        written informed consent form will be obtained from them. Dozee will be placed under the
        mattress of the patient's bed and the data will be collected through the device whenever a
        patient is on the bed.

        The research team members responsible for data analysis will have access only to the fully
        anonymised individual-level data and will be blinded to any other patient data, as well as
        to the components of the calculated scores in the hospital information system.
      
Keywords: Continuous Monitoring; Ballistocardiography; HR; RR; Dozee VS