Wearable Continuous Vital Sign Monitoring Study (WARD-AMS) to Detect Clinical Deterioration in Postoperative General Surgery Patients: Protocol for a Randomized Controlled Trial.

Background: Postoperative complications remain a major challenge in health care systems, with more than 70% of postoperative in-hospital mortality occurring in general wards. Current practice relies on intermittent spot-check monitoring of vital signs guided by track-and-trigger thresholds such as early warning scores. Evidence shows that, up to 4 hours before an adverse event, abnormal vital signs can be detected in up to 60% of patients. Continuous vital sign monitoring in general wards offers the potential to detect clinical deterioration earlier. However, prospective evaluations of continuous monitoring in general wards remain limited. Objective: This study aims to prospectively evaluate the impact of continuous vital sign monitoring in adult postoperative patients in general wards. The primary objective is to determine whether continuous vital sign monitoring reduces the time from device-defined physiological deterioration to the first objective escalation event (acknowledgment or clinical action) by the health care team. Secondary objectives are to evaluate clinical outcomes, operational impact, and both staff and patient experiences. Methods: We conducted a single-center, open-label randomized controlled trial of 200 general surgical patients, receiving continuous vital signs monitoring alongside standard care. Participants were randomized 1:1 to alerting or nonalerting groups, either real-time data and alerts visible or blinded to clinicians, respectively. The primary outcome is the time from the first device-defined physiological deterioration episode to the first objective escalation event (acknowledgment or clinical action). Exploratory outcomes evaluate time to treatment initiation, rapid response team activation, escalation of care, length of stay, mortality, alarm performance, and patient and staff experience. Results: The Ward Alerting and Ambulatory Monitoring Study (WARD-AMS) trial received ethical approval in April 2024; recruitment commenced in October 2024 and was completed by December 2025 with 200 patients enrolled. Data analysis is ongoing, with results to be submitted for publication by mid-2026. Conclusions: The WARD-AMS study is among the first prospective, randomized evaluations of continuous vital sign monitoring in real-world ward settings looking at clinical outcomes and user experience. By integrating clinical outcomes, alarm analytics, and stakeholder experiences, it aims to provide a comprehensive understanding of the benefits, limitations, and implementation challenges of continuous monitoring. Findings from this study will inform strategies to optimize response to early clinical deterioration, reducing alarm fatigue and embedding new technologies into existing routine ward practice.