Artificial Intelligence-augmented Perioperative Clinical Decision Support

Not Applicable

Recruiting

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

• Registration Number: NCT05284227
• Lead Sponsor: Wuerzburg University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Study Start: 2023-04-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical Decision Support Application guided Anaesthesiological Assessment	Electronic Clinical Decision Support Application	Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application.
Standard Anaesthesiological Assessment	Standard procedures of the hospital and Sham Clinical Decision Support Application	Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application.

Primary Outcome Measures

Name	Time	Method
Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist	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 Outcome Measures

Name	Time	Method
Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment	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.
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
Incidence of intra- and postoperative complications	operative procedure until hospital discharge, assessed up to 4 weeks

Trial Locations

Locations (1)

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Bavaria, Germany