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OpenTrials
Completed

NCT Number: NCT05284227

Artificial Intelligence-augmented Perioperative Clinical Decision Support

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).

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Key information

Conditions

ASA Class III/IV Patients Clinical Decision Support Systems Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: preoperative assessment until operative procedure

    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)

Secondary outcomes

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

    Time frame: preoperative assessment until operative procedure

    Completeness of medical documentation will be measured by the number of documented items from a predefined list of relevant cardiovascular symptoms and conditions during the preoperative anaesthesiological asssessment.

  2. Incidence of intra- and postoperative complications

    Time frame: operative procedure until hospital discharge, assessed up to 4 weeks

  3. Incidence of 30-Day unplanned All-cause Hospital Readmission

    Time frame: hospital discharge until 30th postoperative day

  4. Length of Hospital Stay

    Time frame: hospital admission until hospital discharge, assessed up to 4 weeks

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

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

Registry information

Acronym: KIPeriOP

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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