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

Completed

Conditions studied: No Specific Medical Conditions or Disease States

In brief

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.

Key facts

Study ID

NCT05380102

Run by

Turtle Shell Technologies Pvt. Ltd.

People needed

51

Starts

2022-04-28

Expected to finish

2022-06-10

Last updated by the study team

2022-07-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Eastside Research Associates — Redmond, Washington, United States

Full record on ClinicalTrials.gov

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