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Completed

NCT Number: NCT05380102

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

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.

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Key information

Conditions

No Specific Medical Conditions or Disease States

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastside Research Associates

Redmond, Washington, 98052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemetry monitoring

Device

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).

Continuous monitoring through Earlysense

Device

EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements

Continuous monitoring through Dozee VS

Device

Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements

Primary outcomes

  1. Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate

    Time frame: 12 Months

    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.

  2. RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate

    Time frame: 12 Months

    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.

  3. RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate

    Time frame: 12 Months

    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.

  4. RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate

    Time frame: 12 Months

    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.

Secondary outcomes

  1. Motion Notification Accuracy - Device Under Investigation (DUI) (%)

    Time frame: 12 Months

    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.

  2. Bed Exit Notification Accuracy - DUI (%)

    Time frame: 12 months

    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.

  3. Motion Notification Accuracy - Predicate (%)

    Time frame: 12 months

    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.

  4. Bed Exit Notification Accuracy - Predicate (%)

    Time frame: 12 months

    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.

Other outcomes

  1. Comparison of Root Mean Square (RMS) values of the two primary objectives

    Time frame: 12 Months

    Descriptive statistics will be used for capturing study population demographics.

    Investigators will sync timings across the three devices to be able to map concurrent readings and use the longest recorded rate as rate limiting step. (If one device can give 15 second data the other 30s and the third 60s, investigators will use 60s)

Sponsors and collaborators

Lead sponsor

Turtle Shell Technologies Pvt. Ltd.

Industry

Collaborators

  • Eastside Research Associates
  • HealthMinds

Registry information

Official study title

Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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