Validation of continuous monitoring of body vitals by Dozee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1. Mean Absolute Error of Dozee’s Heart Rate and Gold Standard Devices heart rate
Study Overview
Brief Summary
The present study aims to:
1. Validate Dozee HR and RR considering Patient Monitoras gold standard.
2. Verify the EarlySense System HR and RRconsidering Patient Monitor as gold standard.
3. The study separately intended to show anon-inferiority trial of the Investigational device with the Predictive devicei.e EarlySense System.
Dozee device developedby Turtle Shell Technologies Pvt. Ltd., is intended for contactless continuousmonitoring of vital parameters (HR and RR), and screening for abnormal changesin these parameters. The device uses the concept of ballistocardiography anddeploys piezoelectric sensors to capture the micro-vibrations originating fromcardiac contractions, upper respiratory tract activity and body movements. Thisdata is then analyzed by a proprietary algorithm and the values of the vitalparameters are generated. The device is intended to be used to monitorindividuals/patients greater than eighteen years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signsduring sleep and resting state. The setup includes placing a sensor under themattress, and a bedside unit on a nearby flat surface. The other components ofthe setup are Power cords and Power adapter. Thus, a power outlet withsufficient plug sockets near the bed will be required.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults Male or female.
- •(Above 18 years of age)
- •Provide written informed consent.
- •Weight between 40kg/88.18lbs and 120kg/264.55lbs
- •Are stable ICU patients or patients admitted in wards.
Exclusion Criteria
- •Are connected to a device that 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.
Outcomes
Primary Outcomes
1. Mean Absolute Error of Dozee’s Heart Rate and Gold Standard Devices heart rate
Time Frame: At Baseline at the time of patient enrolment into the study
2. Mean Absolute Error of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate
Time Frame: At Baseline at the time of patient enrolment into the study
Secondary Outcomes
- 1. Root Mean Square Difference of Dozee’s Heart Rate and Gold Standard Devices heart rate(2. Root Mean Square Difference of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate)