Performance of a cuffless photoplethysmography-based device for continuous monitoring of blood pressure after cardiac surgery: a preliminary validation study.

Accurate and convenient monitoring of blood pressure (BP) is challenging and relies on cuff-based devices or in the postoperative/intensive care settings, on invasive measurements. The aim of this study was to prospectively evaluate the accuracy of BP measurements obtained from a novel, commercially available cuffless, non-invasive photoplethysmography (PPG)-based chest patch monitor in patients after cardiac surgery. This single center prospective preliminary validation study enrolled adults who underwent cardiac surgery. Data generated by the PPG-based device was compared to those of a standard invasive arterial pressure (IAP). Bland-Altman plots and Pearson's correlations were used to assess the accuracy of the PPG-based device. Stability and BP changes were not formally evaluated. Ninety-six patients consented for the study. Mean age was 63.2 ± 12.2 years (range 24-84), and 32 (33%) were women. Average monitoring was 25.6 ± 17.2 h. In total, we evaluated 78,659 readings for systolic BP (SBP), 78,818 for diastolic BP (DBP), and 92,544 for heart rate (HR). The correlation coefficients were r = 0.959, 0.973, 0.966, and 0.962 for SBP, DBP, mean arterial pressure (MAP), and (HR), respectively. The bias ± SD was 0.1 ± 4.8 mmHg for SBP; 0.4 ± 2.1 mmHg for DBP; 0.26 ± 2.6 mmHg for MAP, and 0.15 ± 3.6 beats per minutes for HR. 95% of SBP, and 99.9% of DBP measurements were within 10 mmHg of the reference measurement. In conclusion, the tested cuffless device offers acceptable accuracy and is a promising novel noninvasive tool for continuous BP monitoring. Further studies are needed to validate these findings according to the most updated validation protocols for pulseless devices.ClinicalTrials.gov ID NCT04071015. Demonstrating (A) patient's flow chart; (B) Photoplethysmography sensor principals of action; (C) Study design, parallel measurement of IAP and cuffless device for patients in ICCU; and (D) the main results of the study.Blood pressure (BP), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), and Heart rate (HR).