Artificial Intelligence-augmented Perioperative Clinical Decision Support

Surgery Clinical Trial

— KIPeriOP  

Official title:

Artificial Intelligence-augmented Perioperative Clinical Decision Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284227
• Other study ID #: KIPeriOP 2022
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Wuerzburg University Hospital
• Contact: Sebastian Hottenrott, M.D.
• Phone: +4993120130563
• Email: hottenrott_s[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• non-cardiac surgery

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Clinical Decision Support Systems
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (7)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Asklepios Kliniken Hamburg GmbH, Charite University, Berlin, Germany, Fraunhofer Institute for Digital Medicine MEVIS, Goethe University, RWTH Aachen University, Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of intra- and postoperative complications		operative procedure until hospital discharge, assessed up to 4 weeks
Secondary	Incidence of 30-Day unplanned All-cause Hospital Readmission		hospital discharge until 30th postoperative day
Secondary	Length of Hospital Stay		hospital admission until hospital discharge, assessed up to 4 weeks