ASA Class III/IV PatientsKIPeriOPNCT05284227
Artificial Intelligence-augmented Perioperative Clinical Decision Support
A study testing Electronic Clinical Decision Support Application in people with ASA Class III/IV Patients and Surgery, run by Wuerzburg University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASA Class III/IV Patients, Surgery, Clinical Decision Support Systems
- What is being tested?
- Electronic Clinical Decision Support Application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anaesthesiologists)-Class III and IV
- non-cardiac surgery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Electronic Clinical Decision Support Application, Standard procedures of the hospital and Sham Clinical Decision Support Application
- Keywords
- Anaesthesiology, Clinical Decision Support, Artificial Intelligence, Perioperative Risk Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Clinical Decision Support ApplicationOther
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 ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support Application guided Anaesthesiological Assessment | Active comparator | Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application. Receives: Other: Electronic Clinical Decision Support Application |
| Standard Anaesthesiological Assessment | Sham comparator | Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application. Receives: Other: Standard procedures of the hospital and Sham Clinical Decision Support Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: preoperative assessment until operative procedure
Secondary outcomes (4)
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.
Measured: preoperative assessment until operative procedure
Incidence of intra- and postoperative complications
Measured: operative procedure until hospital discharge, assessed up to 4 weeks
Incidence of 30-Day unplanned All-cause Hospital Readmission
Measured: hospital discharge until 30th postoperative day
Length of Hospital Stay
Measured: hospital admission until hospital discharge, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start26 Apr 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA Class III/IV PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, Charite University, Berlin, Germany, Asklepios Kliniken Hamburg GmbH, Fraunhofer Institute for Digital Medicine MEVIS, Technical University of Munich, RWTH Aachen University
- Responsible party
- Sponsor
- Investigators
- Patrick Meybohm, M.D., Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284227
- Sponsor's protocol ID
- KIPeriOP 2022
- Acronym
- KIPeriOP
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-augmented Perioperative Clinical Decision Support
- ClinicalTrials.gov ID
- NCT05284227
- Acronym / sponsor ID
- KIPeriOP / KIPeriOP 2022
- Keywords
- Anaesthesiology, Clinical Decision Support, Artificial Intelligence, Perioperative Risk Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Goethe University, Charite University, Berlin, Germany, Asklepios Kliniken Hamburg GmbH, Fraunhofer Institute for Digital Medicine MEVIS, Technical University of Munich, RWTH Aachen University
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support Application guided Anaesthesiological Assessment | Active comparator | Other: Electronic Clinical Decision Support ApplicationPreoperative anaesthesiological assessment and risk evaluation using a clinical decision support application. |
| Standard Anaesthesiological Assessment | Sham comparator | Other: Standard procedures of the hospital and Sham Clinical Decision Support ApplicationPreoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anaesthesiologists)-Class III and IV
- non-cardiac surgery
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Clinical Decision Support ApplicationPreoperative 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. | Other | Clinical Decision Support Application guided Anaesthesiological Assessment |
| Standard procedures of the hospital and Sham Clinical Decision Support ApplicationPreoperative 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. | Other | Standard Anaesthesiological Assessment |
Primary outcome
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)
4 secondary outcomes
Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment
Time frame: preoperative assessment until operative procedure
Incidence of intra- and postoperative complications
Time frame: operative procedure until hospital discharge, assessed up to 4 weeks
Incidence of 30-Day unplanned All-cause Hospital Readmission
Time frame: hospital discharge until 30th postoperative day
Length of Hospital Stay
Time frame: hospital admission until hospital discharge, assessed up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Meybohm, M.D. principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Clinical Decision Support Application in people with ASA Class III/IV Patients and Surgery, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist (time frame: preoperative assessment until operative procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.