Safety, feasibility, and acceptability of a novel device to monitor ischaemic stroke patients van Bohemen, Samuel J. Rogers, Jeffrey M. Alavanja, Aleksandra Evans, Andrew Young, Noel Boughton, Philip C. Valderrama Valenzuela, Joaquín Tomás Kyme, Andre Z. 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. 2025-01-22T08:37:49Z 2025-01-22T08:37:49Z 2024-07 journal article van Bohemen SJ, Rogers JM, Alavanja A, Evans A, Young N, Boughton PC, Valderrama JT, Kyme AZ. Safety, feasibility, and acceptability of a novel device to monitor ischaemic stroke patients. Journal of Medical Enginering & Technology (2024) 48, 173-185. doi: 10.1080/03091902.2024.2409115. https://hdl.handle.net/10481/99892 10.1080/03091902.2024.2409115 eng http://creativecommons.org/licenses/by/4.0/ open access Atribución 4.0 Internacional Taylor and Francis