Artificial Intelligence-augmented Perioperative Clinical Decision Support

NCT ID: NCT05284227

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2024-01-01

Brief Summary

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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

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Conditions

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ASA Class III/IV Patients Surgery Clinical Decision Support Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Clinical Decision Support Application guided Anaesthesiological Assessment

Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application.

Group Type ACTIVE_COMPARATOR

Electronic Clinical Decision Support Application

Intervention Type OTHER

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 Anaesthesiological Assessment

Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application.

Group Type SHAM_COMPARATOR

Standard procedures of the hospital and Sham Clinical Decision Support Application

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Asklepios Kliniken Hamburg GmbH

OTHER

Sponsor Role collaborator

Fraunhofer Institute for Digital Medicine MEVIS

UNKNOWN

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Meybohm, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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University Hospital Wuerzburg

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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KIPeriOP 2022

Identifier Type: -

Identifier Source: org_study_id

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