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Personalised Real-time Interoperable Sepsis Monitoring (PRISM)

NCT06238180 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-04-09

No results posted yet for this study

Summary

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:

1. Can a remote AI-driven monitoring system accurately predict sepsis risk in postoperative patients?
2. 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.

Conditions

  • Sepsis
  • Abdominal Sepsis
  • Infections
  • Clinical Deterioration
  • Hemodynamic Instability

Interventions

DEVICE

PRISM Tool

The intervention in this study involves an AI-driven clinical decision-support system, PRISM Tool, designed for the early prediction of sepsis in patients undergoing abdominal surgery. PRISM Tool integrates data from PPG-based wearable wireless devices that monitor vital signs, electronic health records, and laboratory tests. The AI model analyzes this multimodal data to proactively identify signs of sepsis providing an early warning score to clinicians. The distinguishing feature of this intervention is its use of real-time data and advanced AI analytics to enhance early sepsis detection, aiming to improve patient outcomes in postoperative care.

Sponsors & Collaborators

  • Larissa University Hospital

    collaborator OTHER

  • Technical University of Crete

    collaborator UNKNOWN

  • Aisthesis Medical P.C.

    lead INDUSTRY

Principal Investigators

  • Eleni Arnaoutoglou, MD, PhD · Larissa University Hospital

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238180 on ClinicalTrials.gov