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.TRIAL REGISTRATION: The study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000112763).