Safety, feasibility, and acceptability of a novel device to monitor ischaemic stroke patients

Abstract

This study assessed the safety, feasibility, and acceptability of a novel device to monitor ischaemic stroke patients. The device captured electroencephalography (EEG) and electrocardiography (ECG) data to compute an ECG-based metric, termed the Electrocardiography Brain Perfusion index (EBPi), which may function as a proxy for cerebral blood flow (CBF). Seventeen ischaemic stroke patients wore the device for nine hours and reported feedback at 1, 3, 6 and 9 h regarding user experience, comfort, and satisfaction (acceptability). Safety was assessed as the number of adverse events reported. Feasibility was assessed as the percentage of uninterrupted EEG/ECG data recorded (data capture efficiency). No adverse events were reported, only minor incidences of discomfort. Overall device comfort (mean ± 1 standard deviation (SD) (range)) (92.5% ± 10.3% (57.0–100%)) and data capture efficiency (mean ± 1 SD (range)) (95.8% ± 6.8% (54.8–100%)) were very high with relatively low variance. The device didn’t restrict participants from receiving clinical care and rarely (n = 6) restricted participants from undertaking routine tasks. This study provides a promising evidence base for the deployment of the device in a clinical setting. If clinically validated, EBPi may be able to detect CBF changes to monitor early neurological deterioration and treatment outcomes, thus filling an important gap in current monitoring options.