A cross-sectional study for validation of heart rate, breathing rate, oxygen saturation level and temperature through the remote patient monitor of the pediatric population.

Heart Rate (HR), Respiration Rate (RR), Temperature and Oxygen Saturation (SpO2) are the most common vital signs used by medical professionals to monitor health of the patients. While a pulse oximeter is mostly used only to capture oxygen saturation, it can also be used to measure heart  rate, though ECG remains the gold standard for heart rate measurement. Respiration, on the other hand, is traditionally measured manually by the nursing staff but can also be measured using a nasal thermistor or capnography. Monitoring of these vitals with less cumbersome techniques would be ideal in long term monitoring of patients and healthy people to detect any sudden abnormalities and long-term health deterioration. During COVID-19 pandemic, remote monitoring devices have come up as champions to assist the healthcare workers in patient monitoring. Several advancements have been made in achieving continuous long-term monitoring of vitals using wrist watches, PPG sensors, etc. [1, 2]. But very few of these have been implemented with acceptable accuracy. The Dozee device developed by Turtle Shell Technologies Pvt. Ltd., is a non-contact continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of HR, RR, and continuous measurement of SpO2 and Temperature (when connected with an accessory). 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 – HR and RR are generated. 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 making it ideal when compared to current methods. 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. 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 effectiveness of the investigational device in a general-care clinical environment and in ICU settings in a pediatric population.

References

1. Etiwy M, Akhrass Z, Gillinov L, et al. Accuracy of wearable heart rate monitors in cardiac rehabilitation [published correction appears in Cardiovasc Diagn Ther. 2020 Jun;10(3):644-645]. Cardiovasc Diagn Ther.2019;9(3):262-271. doi:10.21037/cdt.2019.04.08

2. Charlton PH, Bonnici T, Tarassenko L, Clifton DA, Beale R, Watkinson PJ. An assessment of algorithms to estimate respiratory rate from the electrocardiogram and photoplethysmogram. Physiol Meas. 2016;37(4):610-626. doi:10.1088/0967-3334/37/4/610