ASA Class III/IV Patients, Clinical Decision Support Systems, Surgery
Conditions
Keywords
Anaesthesiology, Clinical Decision Support, Artificial Intelligence, Perioperative Risk Assessment
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).
Interventions
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.
OTHERStandard 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.
Sponsors
Goethe University
Charite University, Berlin, Germany
Asklepios Kliniken Hamburg GmbH
Fraunhofer Institute for Digital Medicine MEVIS
Technical University of Munich
RWTH Aachen University
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA (American Society of Anaesthesiologists)-Class III and IV * non-cardiac surgery
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
Countries
Germany
Outcome results
None listed