Clinical trial NCT05380102: Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS
Official title: Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No Specific Medical Conditions or Disease States
Keywords: Continuous Monitoring
Ballistocardiography
HR
RR
Dozee VS
Lead sponsor: Turtle Shell Technologies Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Eastside Research Associates
name: HealthMinds
First posted: 2022-05-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Adults Male or female. (Above 18 years of age)
2. Provide written informed consent.
3. Weight between 40kg/88.18lbs and 120kg/264.55lbs(Above 40 kgs)
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period (2hours or 10 hours accordingly)

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. A likely need to receive or undergo a procedure during the testing period.
4. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
6. Prisoners

Primary outcomes:
measure: Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
timeFrame: 12 Months
measure: RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
timeFrame: 12 Months
measure: RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate
timeFrame: 12 Months
measure: RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
timeFrame: 12 Months
Secondary outcomes:
measure: Motion Notification Accuracy - Device Under Investigation (DUI) (%)
timeFrame: 12 Months
measure: Bed Exit Notification Accuracy - DUI (%)
timeFrame: 12 months
measure: Motion Notification Accuracy - Predicate (%)
timeFrame: 12 months
measure: Bed Exit Notification Accuracy - Predicate (%)
timeFrame: 12 months
Other outcomes:
measure: Comparison of Root Mean Square (RMS) values of the two primary objectives
timeFrame: 12 Months
Locations:
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
Study officials:
References: