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Clinical Trials in the USA / NCT05893420
Active, not recruiting Not applicable

A Rapid Diagnostic of Risk in Hospitalized Patients Using Machine Learning

NCT05893420 · tracked via the Priya Life Science USA tracker
Sponsor
AgileMD, Inc.
Phase
Not applicable
Started
2024-12-31
Last updated
2025-07-29

Condition(s) studied

SepsisSepticemiaRespiratory FailureHemodynamic InstabilityCOVID-19Cardiac ArrestClinical Deterioration

Investigational drug(s) / intervention(s)

eCARTv5 clinical deterioration monitoringStandard of care control

eCARTv5 clinical deterioration monitoring: eCART is a predictive analytic used for the identification of acute clinical deterioration built upon more than a decade of ongoing scientific research and chronicled in numerous peer-reviewed publications. eCART draws upon readily available patient data from the EHR, rapidly quantifies disease severity, and predicts the likelihood of critical illness onset.

Standard of care control: Standard of care is the health system's clinical best practices and workflows for identifying high-risk patients for clinical deterioration, including other tools already built into the electronic health record (EHR). Hospitals that do not implement eCARTv5 will be compared as a control against hospitals that do implement eCARTv5.

Study summary

In this study, the investigators will deploy a software-based clinical decision support tool (eCARTv5) into the electronic health record (EHR) workflow of multiple hospital wards. eCART's algorithm is designed to analyze real-time EHR data, such as vitals and laboratory results, to identify which patients are at increased risk for clinical deterioration. The algorithm specifically predicts imminent death or the need for intensive care unit (ICU) transfer. Within the eCART interface, clinical teams are then directed toward standardized guidance to determine next steps in care for elevated-risk patients.

The investigators hypothesize that implementing such a tool will be associated with a decrease in ventilator utilization, length of stay, and mortality for high-risk hospitalized adults.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 18 years old * Admitted to an eCART-monitored medical-surgical unit (scoring location) Exclusion Criteria: * Younger than 18 years old * Not admitted to an eCART-monitored medical surgical unit (scoring location)

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Yale New Haven Health System New Haven Connecticut
BayCare Health System Clearwater Florida
University of Wisconsin Health Madison Wisconsin

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05893420 on ClinicalTrials.gov ↗ ← All trials in the USA