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Pilot Clinical Evaluation of Dozee VS, a Contactless Continuous Vital Parameters Monitoring System in Hospital Patients

NCT05153460 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-06-03

No results posted yet for this study

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 V 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.

Conditions

  • No Specific Medical Conditions or Disease States

Interventions

DEVICE

Telemetry and manual monitoring vs Contactless monitoring devices

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively). In addition, two contactless monitoring devices will be placed on the patient bed to measure data simultaneously. These devices include EarlySense (USFDA approved ballistocardiography device) and Dozee VS (Investigational Device).

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • HealthMinds

    collaborator UNKNOWN

  • Turtle Shell Technologies Pvt. Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-04-14
Completion
2022-04-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153460 on ClinicalTrials.gov