The Accuracy and Usability of a Novel Continuous Non-Invasive Wearable Vital Signs Monitor

Abstract

Background. Postoperative changes in vital signs (VS) can signal impending complications. While continuous, non invasive wearable monitoring can support frontline nurses’ detection of patients’ physiologic deterioration, current clinical grade wearables are often limited by restricted multiparameter monitoring, cumbersome designs, insufficient regulatory clearance for ambulatory use, and limited user centred development. Objectives. To validate the accuracy of the multiparameter Vitaliti™ Continuous Vital Signs Monitor (CVSM) against regulatory reference standards (e.g., International Organization for Standardization) for heart rate (HR), continuous non invasive blood pressure (CNIBP), SpO₂, pulse rate (PR), respiration rate (RR), and temperature in ambulatory healthy adults, and to assess device usability and wearability among surgical patients, caregivers, nurses, and physicians in Canada and Norway. Methods. Thirty-nine adults wore the Vitaliti™ CVSM alongside Health Canada approved reference devices during 60-second, time synchronized sessions across static (sitting, standing, supine) and active (walking, head motion) conditions. Sample size requirements varied by VS (18–23 participants). Agreement was assessed using Bland–Altman analysis. User testing (N = 65) included structured task analyses, while Canadian patients wore the device for up to 72 hours postoperatively. Usability outcomes and qualitative interview feedback were analyzed. Results. HR met regulatory accuracy criteria across all conditions. CNIBP met regulatory requirements in seated, supine, and head motion conditions but did not meet sample size requirements in all analyses. PR and SpO₂ met validation thresholds in static and most motion conditions. RR showed acceptable agreement under metronome paced breathing conditions but reduced precision with movement. Temperature measurements demonstrated acceptable agreement when seated; however, accuracy thresholds were exceeded in supine conditions. User testing demonstrated high task completion and perceived clinical value, with device removals primarily due to sleep related discomfort from the earpiece sensor and fit. Conclusions. The Vitaliti™ CVSM demonstrated promising regulatory aligned accuracy and was well received across user groups. Further validation and iterative design refinements informed by end-user feedback are required prior to clinical implementation