TY - JOUR
T1 - Validation of a novel contact-free heart and respiratory rate monitor
AU - Havakuk, Ofer
AU - Sadeh, Ben
AU - Merdler, Ilan
AU - Zalevsky, Zeev
AU - Garcia-Monreal, Javier
AU - Polani, Sagi
AU - Arbel, Yaron
N1 - Publisher Copyright:
© 2021 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Vital signs
KW - camera
KW - heart rate
KW - laser
KW - respiratory rate
UR - http://www.scopus.com/inward/record.url?scp=85104688054&partnerID=8YFLogxK
U2 - 10.1080/03091902.2021.1905896
DO - 10.1080/03091902.2021.1905896
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C2 - 33849394
AN - SCOPUS:85104688054
SN - 0309-1902
VL - 45
SP - 344
EP - 350
JO - Journal of Medical Engineering and Technology
JF - Journal of Medical Engineering and Technology
IS - 5
ER -