Validation of a novel contact-free heart and respiratory rate monitor

Abstract

There is a growing need for remote monitoring of patients due to a lack of resources and infection control. Current systems use sensors that require constant physical contact with the user, which may result in discomfort or lack of adherence. In the present study, we evaluated the accuracy of a new contact-free system to monitor heart and respiratory rate. Study participants were measured simultaneously using two devices: a contact-free optical system that measures nano-vibrations and movements (investigational device, “Gili Pro BioSensor”) and a standard reference bed-side monitor, inclusive of an electrocardiogram and capnograph modules (Mindray^®). Co-primary endpoints included HR and RR accuracy in subjects without active arrhythmias for HR, and for all study populations for RR (i.e., for subjects with and without active arrhythmias). Confirmatory secondary endpoints included HR scored continuously for all study populations, inclusive of subjects with arrhythmias. The present study included 115 patients who completed study procedures. Mean age was 66 ± 14.6 (range 29–93) with 60% males, 31% obese patients (i.e., BMI > 30 kg/m², range 17–44) and 56% measured in a chair. For the dichotomised accuracy analysis, both co-primary endpoint for HR and RR resulted in 100% accuracy (95% CI: HR 98.8–100%; RR 98.9–100%), whereas for the confirmatory secondary analysis, 99.1% of the HR measurements across subjects with and without active arrhythmias were deemed accurate (95% CI: 97.4–99.8%). The current study demonstrated over 99% accuracy in detecting heart and respiratory rate using a novel contact-free optical system.

Keywords:

• Vital signs
• heart rate
• respiratory rate
• laser
• camera

Disclosure statement

Sagi Polani, Zeev Zalevsky, Javier Garcia-Monreal and Yaron Arbel hold equity with Donisi Health.

Additional information

Funding

This study was funded by Donisi Health.