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

NCT05153460 | Terminated DMC FDA Device

• 2 other identifiers: DozeeUSFDA2021STUDY00001760
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Continuous Monitoring, Ballistocardiography, HR, RR, DozeeVS

Outcome Measures

Primary Outcomes (4)

• RMSD of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate

  Record heart rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the root mean square difference (RMSD) per patient and Bland-Alman plot of the heart rate for the investigational device and the gold standard device.

  12 months

• RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate

  Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the root mean square difference (RMSD) per patient and Bland-Alman plot of the respiratory rate for the investigational device and the gold standard device.

  12 months

• RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate

  Record heart rate in the predicate device and patient monitor at the same time every 60 seconds. Calculate and compare the root mean square difference (RMSD) per patient and Bland-Alman plot of the heart rate for the predicate device and the gold standard device.

  12 months

• RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate

  Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the root mean square difference (RMSD) per patient and Bland-Alman plot of the respiratory rate for the predicate device and the gold standard device.

  12 months

Secondary Outcomes (4)

• Motion Notification Accuracy - DUI (%)

  12 months

• Bed Exit Notification Accuracy - DUI (%)

  12 months

• Motion Notification Accuracy - Predicate (%)

  12 months

• Bed Exit Notification Accuracy - Predicate (%)

  12 months

Other Outcomes (1)

• Comparison of RMS values of the two primary objectives

  12 months

Study Arms (1)

Single Arm Study (Cohort)

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

Device: Telemetry and manual monitoring vs Contactless monitoring devices

Interventions

Telemetry and manual monitoring vs Contactless monitoring devices DEVICE

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).

Also known as: EarlySense, Dozee VS

Single Arm Study (Cohort)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Turtle Shell Technologies Pvt. Ltd.: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• HealthMinds: collaborator

Study Sites (1)

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Interventions

Telemetry

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: December 9, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)