Artificial Intelligence-augmented Perioperative Clinical Decision Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA (American Society of Anaesthesiologists)-Class III and IV
- •non-cardiac surgery
Exclusion Criteria
- Not provided
Arms & Interventions
Clinical Decision Support Application guided Anaesthesiological Assessment
Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application.
Intervention: Electronic Clinical Decision Support Application (Other)
Standard Anaesthesiological Assessment
Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application.
Intervention: Standard procedures of the hospital and Sham Clinical Decision Support Application (Other)
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)