Use of a Continuous Single Lead Electrocardiogram Analytic to Predict Patient Deterioration Requiring Rapid Response Team Activation

Identifying the onset of patient deterioration is challenging despite the potential to respond to patients earlier with better vital sign monitoring and rapid response team (RRT) activation. In this study an ECG based software as a medical device, the Analytic for Hemodynamic Instability Predictive Index (AHI-PI), was compared to the vital signs of heart rate, blood pressure, and respiratory rate, evaluating how early it indicated risk before an RRT activation. A higher proportion of the events had risk indication by AHI-PI (92.71%) than by vital signs (41.67%). AHI-PI indicated risk early, with an average of over a day before RRT events. In events whose risks were indicated by both AHI-PI and vital signs, AHI-PI demonstrated earlier recognition of deterioration compared to vital signs. A case-control study showed that situations requiring RRTs were more likely to have AHI-PI risk indication than those that did not. The study derived several insights in support of AHI-PI’s efficacy as a clinical decision support system. The findings demonstrated AHI-PI’s potential to serve as a reliable predictor of future RRT events. It could potentially help clinicians recognize early clinical deterioration and respond to those unnoticed by vital signs, thereby helping clinicians improve clinical outcomes. ### Competing Interest Statement Authors: Bryce Benson and Ashwin Belle are currently employed by Fifth Eye Inc. Authors: Sooin Lee was previously employed by Fifth Eye Inc. Authors: Bryce Benson, Ashwin Belle, and Kevin Ward have patents and equity interest in Fifth Eye Inc. ### Funding Statement The author(s) received no specific funding for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: University of Michigan IRB approval (HUM00092309) was obtained before conducting this study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes This data is owned exclusively by University of Michigan and was used for this analysis with an established data use agreement between Fifth Eye Inc. and the University of Michigan under a cleared IRB. Please reach out to the following University of Michigan personnel for your access to data. Phil Jacokes, Managing Director, Weil Institute pjacokes@umich.edu