Artificial Intelligence-augmented Perioperative Clinical Decision Support (KIPeriOP)

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).

Study Overview

• Status: Recruiting
• Conditions: Surgery; ASA Class III/IV Patients; Clinical Decision Support Systems
• Intervention / Treatment: Other: Electronic Clinical Decision Support Application; Other: Standard procedures of the hospital and Sham Clinical Decision Support Application

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Hottenrott, M.D.; Phone Number: +4993120130563; Email: hottenrott_s@ukw.de
• Study Contact Backup: Name: Pamela Bendz, M.D.; Phone Number: +4993120130579; Email: bendz_p@ukw.de

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital Wuerzburg
      • Contact: Sebastian Hottenrott, MD; Email: hottenrott_s@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical Decision Support Application guided Anaesthesiological Assessment; Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application.	Other: Electronic Clinical Decision Support Application; 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.
Sham Comparator: Standard Anaesthesiological Assessment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment	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.	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

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: Charite University, Berlin, Germany; Goethe University; RWTH Aachen University; Technical University of Munich; Asklepios Kliniken Hamburg GmbH; Fraunhofer Institute for Digital Medicine MEVIS
• Investigators: Principal Investigator: Patrick Meybohm, M.D., Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Artificial Intelligence; Anaesthesiology; Perioperative Risk Assessment
• Other Study ID Numbers: KIPeriOP 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No