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Clinical Trials/NCT05284227
NCT05284227
Completed
Not Applicable

Artificial Intelligence-augmented Perioperative Clinical Decision Support

Wuerzburg University Hospital1 site in 1 country210 target enrollmentApril 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ASA Class III/IV Patients
Sponsor
Wuerzburg University Hospital
Enrollment
210
Locations
1
Primary Endpoint
Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist
Status
Completed
Last Updated
9 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 26, 2023
End Date
January 1, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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 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)

Study Sites (1)

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