Personalised Real-time Interoperable Sepsis Monitoring (PRISM)

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Description

The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery. The main questions it aims to answer are:

Can a remote AI-driven monitoring system accurately predict sepsis risk in postoperative patients?
How effectively can this system integrate and analyze multimodal data for early sepsis detection in the surgical ward?

Participants are equipped with non-invasive PPG-based wearable devices to continuously monitor vital signs and collect high-quality clinical data. This data, along with demographic and laboratory information from the Electronic Health Record (EHR) of the hospital, are used for AI model development and validation.

Study Overview

Start Date
November 29, 2023
Completion Date
March 31, 2024
Enrollment
80
Date Posted
February 2, 2024
Gender
All

Locations

Full Address
General University Hospital of Larissa
Larissa, Thessaly 41110, Greece

Eligibility

Study Population
The study population for the observational study on sepsis prediction are postoperative abdominal surgery patients >18 years of age, selected from a hospital setting, specifically targeting patients admitted for abdominal surgery. This includes a diverse demographic of adult patients undergoing various types of abdominal surgeries. The selection will focus on ensuring a representative sample of this patient group to accurately assess the efficacy and applicability of the AI-driven sepsis prediction system in a real-world clinical environment.
Minimum Age (years)
18
Maximum Age (years)
120
Eligibility Criteria
Inclusion Criteria:

Patients undergoing elective abdominal surgery.
Postoperative admission to the surgical ward.
Age 18 years or older, who are able and willing to participate and have given written consent.
On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high.

Exclusion Criteria:

<18 years of age Known allergy or contraindication to the monitoring devices.
Pre-existing conditions that could interfere with the study (e.g., chronic sepsis, immunodeficiency disorders).
Day case surgery.
Pregnancy.
Immediate transfer to ICU postoperatively.
Patient refusal or unable to give written consent.

Study Contact Info

Study Contact Name
Eleni Arnaoutoglou, MD, PhD; Ioannis Gkouzionis, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06238180