A Retrospective Observational Study of Continuous Wireless Vital Sign Monitoring via a Medical Grade Wearable Device...

Background: Continuous vital sign monitoring via wearable technology, combined with algorithm-based notifications, has been utilized for early detection of patient deterioration. In this retrospective observational study, we summarize a large-scale implementation of a continuous monitoring system in medical-surgical units of two hospitals over the course of fifteen (15) months. Methods: An FDA-cleared wireless monitoring device (BioButton^®, BioIntelliSense Inc., Golden, CO, USA), was placed on each patient upon admission. The wearable device measures heart rate and respiratory rate at rest, skin temperature, and patient activity levels. High-frequency data (up to 1440 measurements per day) are transmitted to display in exception management software (BioDashboard™, version 2.9, BioIntelliSense Inc.). Algorithmic and rules-based notifications are triggered based on clinical and statistical trending criteria. We present (i) agreement of device readings with bedside charted measurements, (ii) the frequency of notifications, (iii) the occurrence of notifications prior to clinical deterioration events, and (iv) impact on clinical management, including early data on length of stay (LOS). Results: In total, 11,977 patient encounters were monitored at two sites. Bias ±95% limits of agreement were 1.8 ± 12.5 for HR and 0.4 ± 8.0 for RR. The rates of notifications were 0.97 and 0.65 per patient-day at Sites 1 and 2, respectively. Among clinical deteriorations, 73% (66%) had at least one notification within 24 h prior at Site 1 (Site 2). At Site 1, there were 114 cases for which a notification led to a new or changed physician's order. LOS in the first unit monitored by the system exhibited a decreasing trend from 3.07 days to 2.75 days over 12 months. Conclusions: Wearable continuous vital sign monitoring with the BioIntelliSense BioButton^® system enables early detection of clinical deterioration.