Artificial Intelligence-augmented Perioperative Clinical Decision Support

NCT05284227 | Completed

• 1 other identifier: KIPeriOP 2022
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates a novel anaesthesiological clinical decision support (CDS) application, that integrates risk evaluation tools and updated clinical guidelines guided by artificial intelligence in the setting of preoperative anaesthesiological assessment. It will be compared to the current standard preoperative assessment workflow with participants being actual patients. 480 participants will be randomly assigned to either the CDS group (preoperative assessment using the CDS application) or the Control group (standard preoperative assessment workflow).

Conditions

ASA Class III/IV Patients; Surgery; Clinical Decision Support Systems

Keywords

Anaesthesiology; Clinical Decision Support; Artificial Intelligence; Perioperative Risk Assessment

Outcome Measures

Primary Outcomes (1)

• Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist

  Preoperative diagnostic procedures ordered by the anaesthesiologist are defined as ECG, echocardiography, carotid (Duplex) ultrasound, chest X-ray and functional non-invasive tests for coronary artery disease (e.g. stress echocardiography)

  preoperative assessment until operative procedure

Secondary Outcomes (4)

• Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment

  preoperative assessment until operative procedure

• Incidence of intra- and postoperative complications

  operative procedure until hospital discharge, assessed up to 4 weeks

• Incidence of 30-Day unplanned All-cause Hospital Readmission

  hospital discharge until 30th postoperative day

• Length of Hospital Stay

  hospital admission until hospital discharge, assessed up to 4 weeks

Study Arms (2)

Clinical Decision Support Application guided Anaesthesiological Assessment

ACTIVE COMPARATOR

Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application.

Other: Electronic Clinical Decision Support Application

Standard Anaesthesiological Assessment

SHAM COMPARATOR

Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application.

Other: Standard procedures of the hospital and Sham Clinical Decision Support Application

Interventions

Electronic Clinical Decision Support Application OTHER

Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application, that calculates perioperative risks for the patient and informs the anaesthesiologist on indicated diagnostics and procedures according to clinical guidelines in real-time.

Clinical Decision Support Application guided Anaesthesiological Assessment

Standard procedures of the hospital and Sham Clinical Decision Support Application OTHER

Preoperative anaesthesiological assessment using standard procedures of the hospital. In addition a sham clinical decision support application will be used. Information on perioperative risks and indicated diagnostic procedures according to clinical guidelines is not given to the physician.

Standard Anaesthesiological Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anaesthesiologists)-Class III and IV
• non-cardiac surgery

You may not qualify if:

• none

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Goethe University: collaborator
• Charite University, Berlin, Germany: collaborator
• Asklepios Kliniken Hamburg GmbH: collaborator
• Fraunhofer Institute for Digital Medicine MEVIS: collaborator
• Technical University of Munich: collaborator
• RWTH Aachen University: collaborator

Study Sites (1)

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Study Officials

• Patrick Meybohm, M.D.

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 17, 2022
• Study Start: April 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)