Personalised Real-time Interoperable Sepsis Monitoring (PRISM)

Completed

• Conditions: Sepsis; Abdominal Sepsis; Clinical Deterioration; Infections; Hemodynamic Instability

• Registration Number: NCT06238180
• Lead Sponsor: Aisthesis Medical P.C.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of AI-Driven Sepsis Prediction in Postoperative Period	The accuracy of sepsis prediction will be assessed from the day of surgery, assessed daily for up to 7 days post-surgery or until hospital discharge.	This primary outcome measure evaluates the accuracy of the AI-driven monitoring system, VIOSync SPI, in predicting postoperative sepsis among patients undergoing abdominal surgery. The measure focuses on the system's ability to correctly identify sepsis, considering sensitivity, specificity, and predictive values.

Trial Locations

Locations (1)

General University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece