NCT05380102

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

Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Turtle Shell Technologies Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• No Specific Medical Conditions or Disease States

Interventions

Type	Name	Description
DEVICE	Telemetry monitoring	All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).
DEVICE	Continuous monitoring through Earlysense	EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements
DEVICE	Continuous monitoring through Dozee VS	Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements

Timeline

• Start date: 2022-04-28
• Primary completion: 2022-06-03
• Completion: 2022-06-10
• First posted: 2022-05-18
• Last updated: 2022-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study