Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate

Abstract

Recently, photoplethysmography-based vital parameter measurements have increased in popularity. However, clinical evaluation of these measurements is lacking. The objective of this study was to rigorously evaluate the clinical accuracy and reliability of a novel photoplethysmography-based wristband for measuring key vital parameters-oxygen saturation (SpO2), respiratory rate (RR), and pulse rate (PR)-during heart catheterisations. Vital parameters obtained during heart catheterisations by means of a photoplethysmography-based wristband (CardioWatch 287-2, Corsano Health) were compared to reference measurements performed by a Nellcor fingerclip (SpO2, PR) as well as a 5-lead ECG (RR) (QMAPP Haemodynamic Monitoring module, Fysicon B.V.) by means of correlation coefficients and root means squared error (RMSE). Effects of skin colour and arm hair density were additionally evaluated. In total, 945 samples from a total of 100 patients were included in the analysis. The correlation coefficients and RSME obtained for the difference between reference and photoplethysmography-based wristband measurements were r = 0.815 and 1.6% for SpO2, r = 0.976 and 0.9 brpm for RR, and r = 0.995 and 1.3 bpm for PR. Similar results were obtained across all skin colour and arm hair density subcategories. This study shows that photoplethysmography-based SpO2, RR, and PR measurements can be accurate during heart catheterisations. Future investigations are required to evaluate the wristband's performance under dynamic circumstances as well as over an extended time period. Trial registration: www.clinicaltrials.gov, NCT05566886.

Keywords: Clinical evaluation; Oxygen saturation; Photoplethysmography; Pulse rate; Respiratory rate.