Perioperative Risk Calculator

Perioperative/Postoperative Complications Clinical Trial

— PROTECT  

Official title:

Machine-learning Model for Perioperative Risk Calculation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04092933
• Other study ID #: 253/19
• Status: Active, not recruiting
• Start date: May 1, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this project is to develop a machine-learning model for calculating the risk of postoperative complications. In addition to the data collected during the premedication, the model will include all intraoperative values recorded in the Patient Data Management System (PDMS), which include not only vital and respiratory parameters, but also medication and doses, intraoperative events and times. Postoperative complications are defined according to their severity according to the Clavien-Dindo score (Dindo, Demartines et al., 2004) and are collected from the data available in the health information system (HIS).

The machine-learning model is created using an extreme-gradient boosting algorithm which has been updated with new data from the year 2021 to ensure accuracy of the model.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175559
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients who underwent surgery with anesthesia

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	Health Information Management, Belgium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	Postoperative complications are classified by means of the Clavien-Dindo-Score.; The Clavien-Dindo-Score describes classes of severity of postoperative complications: Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II: requiring pharmacological treatment Grade IIIa: requiring surgical, endoscopic or radiological intervention not under general anesthesia Grade IIIb: requiring surgical, endoscopic or radiological intervention under general anesthesia Grade IVa: single organ dysfunction Grade IVb: multiorgandysfunction Grade V: death of a patient	30 days
Secondary	in-hospital mortality	mortality within hospital stay	30 days