Integration of NAVOY® Sepsis in an Electronic Health Record System

Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05095220

Acronym

GENIUS

Enrollment

1000

Registered

2021-10-27

Start date

2022-05-27

Completion date

2023-03-08

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, ICU, prediction, decision support, machine learning, intensive care

Brief summary

The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The subject is admitted to the ICU during the enrolment period. * The subject is 18 years of age or older at the time of admission to the ICU.

Exclusion criteria

* None.

Design outcomes

Primary

Measure	Time frame	Description
NAVOY® Sepsis prediction performance	6 months	NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management.

Secondary

Measure	Time frame	Description
Integration validation	6 months	A technical checklist will be used in order to validate the integration between NAVOY® Sepsis and the electronic health record system.
NAVOY® Sepsis prediction results	6 months	The NAVOY® Sepsis predictions results indicate if the subject is at risk of developing sepsis within the coming hours. The results are not made available to ICU staff.
Fulfilment of Sepsis-3 criteria	6 months	The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.
Sepsis specific management	6 months	Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.

Countries

Sweden

Outcome results