Clinical Validation of an Indigenous Micro-Vibration Vital Parameter Monitor Dozee VS

Abstract

Continuous monitoring of heart rate (HR) and respiratory rate (RR) has shown potential to reduce hospital mortality and morbidity. Devices based on ballistocardiography (BCG) can continuously monitor vital signs in a continuous and contactless manner. The BCG-based Dozee VS (part of the Dozee family of devices) from Turtle Shell Technologies Pvt. Ltd. is designed for continuous and contactless measurement of HR, RR, movement, and bed occupancy. This paper focuses on the final field validation of the Dozee VS system. Three clinical investigations, (India 2 & USA 1), were conducted on 120 patients to validate Dozee VS's claims and safety. These studies compared HR and RR from Dozee VS to a US FDA-cleared BCG system, EarlySense 2.0, and a US FDA-cleared patient monitor that employs capnography (EtC02) waveforms to determine RR and electrocardiography (ECG) waveforms to determine HR. In addition, we compared Dozee and EarlySense's movement and bed-exit detection accuracy to manual observations. Over 14000 HR and RR data points for both Dozee VS and EarlySense were analyzed. Dozee's HR mean absolute error (MAE) was 2.48 beats/minute and RR MAE was 1.67 breaths/minute against the gold standard. For Dozee against EarlySense, the HR MAE was 2.31 beats/minute and RR MAE was 1.42 breaths/minute. Dozee VS had a 94.5% movement detection accuracy and an 88.5% bed-exit detection accuracy, whereas EarlySense had a 98% movement detection accuracy and a 96.5% bed-exit detection accuracy. Thus, in terms of accuracy as well as a comfortable contactless patient monitoring solution, BCG, specifically Dozee, can be considered a clinically viable system.