Patient SafetyNCT06574906
Machine Learning Prediction of Parameters of Early Warning Scores in General Wards
An observational study of Patient Safety, run by Kepler University Hospital at 1 site in Austria.
Trial summary
In the event of illness or injury, patients are medically evaluated and initially treated in acute medical outpatient clinics, emergency rooms and surgeries. If medically indicated, care and treatment can also be provided in hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety
- What is being tested?
- Parameters of Early Warning Scores
- How many people
- 3,000 participants
- Where
- 1 siteAustria
- Study dates
- 15 Aug 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated in general wards.
Who may be able to join
- Treated in general ward between 2024-10-01 and 2026-10-31 at the study center.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Johannes Kepler University, Kepler University Hospital
Linz, Upper Austria, 4020
About this study
In the event of illness or injury, patients are medically evaluated and initially treated in acute medical outpatient clinics, emergency rooms and surgeries. If medically indicated, care and treatment can also be provided in hospital. Depending on the severity of the illness and the main medical problem, this care is provided on hospital wards, which are primarily looked after by specific specialist disciplines and assigned to them in the form of clinical departments, for example.
As part of the inpatient stay, treatment and care is usually provided through ward rounds by the medical staff. However, ward rounds are spot checks of individual measured values at predefined times.
Read more
Qualified nursing staff carry out the agreed treatment plans and check the patient's general condition several times a day. In contrast to intensive medical monitoring, however, there is no continuous monitoring and therefore an aggravation of a patient's condition is not always immediately apparent. Furthermore, in addition to known complications of existing conditions, new or unexpected complications can also occur.
Although non-intensive care monitoring is based on discontinuous monitoring, incidents and complications can sometimes be life-threatening, especially if there is no immediate response to a deterioration in the patient's condition. Even if there are early warning systems such as scores, their ability to react is limited, partly due to the frequency with which they are collected.
In addition to patient-specific limitations of inpatient monitoring, such as patient cooperation in the sense of self-monitoring, medical limitations, such as the frequency of the survey, there are also economic limitations, such as the availability of staff who can be deployed for more frequent monitoring.
Although there are telemedical approaches to monitoring, setting these up is often limited both economically and by the additional training required, for example.
Even if threshold values are (or can be) defined for the measured data (vital signs, laboratory parameters, clinical impression and others), if these are exceeded or not reached, a consequence, e.g. a therapy step, can only be initiated retrospectively. In this situation, a pathophysiological change is already so far advanced that in many cases a compensation mechanism no longer functions adequately and turns into a decompensation situation. In this situation, the affected patients in a hospital ward are potentially in mortal danger.
One way of averting the dangers described above could be to use a reduced combination of monitoring methods compared to intensive care monitoring. At the same time, the use of artificial intelligence enables the automated evaluation of the collected data and can thus lead to the prediction of changes in parameters, which enables early alerting, i.e. before the occurrence of pathophysiological decompensation.
- Conditions
- Patient Safety
- Being tested
- Parameters of Early Warning Scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parameters of Early Warning ScoresOther
Parameters of Early Warning Scores
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of the Receiver Operating Characteristic (AUC-ROC) for Prediction of Parameters of Early Warning Scores
Area Under the Curve of the Receiver Operating Characteristic (AUC-ROC) for Prediction of Parameters of Early Warning Scores
Measured: 2024-10-01 to 2026-10-31
Area Under the Curve of the Precision-Recall Curve (AUC-PRC) for Prediction of Parameters of Early Warning Scores
Area Under the Curve of the Precision-Recall Curve (AUC-PRC) for Prediction of Parameters of Early Warning Scores
Measured: 2024-10-01 to 2026-10-31
F-Beta Score with Beta = 1 (F1-Score) for Prediction of Parameters of Early Warning Scores
F-Beta Score with Beta = 1 (F1-Score) for Prediction of Parameters of Early Warning Scores
Measured: 2024-10-01 to 2026-10-31
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Measured: 2024-10-01 to 2026-10-31
Secondary outcomes (6)
SHapley's Additive exPlanations (SHAP) Values for Prediction Models
SHapley's Additive exPlanations (SHAP) Values for Prediction Models
Measured: 2024-10-01 to 2026-10-31
Prediction of Routine Laboratory Values
Routine laboratory values measurements collected in routine care; this comprises organ function measures such as liver function tests, and in turn more specifically aspartate-aminotransferase (ASAT), alanine transaminase (ALAT), cholinesterase (CHE). Predictions are made on their future values in the respective units they are measured in.
Measured: 2024-10-01 to 2026-10-31
Prediction of Parameters Measured by Photophlethysmogram (PPG)
Future values of the photophlethysmogram (PPG) are predicted; this comprises heart rate, respiration rate, peripheral oxygen saturation Predictions are made on their future values in the respective units they are measured in.
Measured: 2024-10-01 to 2026-10-31
Prediction of Medical Emergency Team or Emergency Critical Care Treatment
In case of deterioration, patients are examined by a medical emergency team (MET) at the ward they are admitted to, if necessary stabilized there or referred to a specialized emergency critical care (ECC) area for further examination and treatment. Both, MET and ECC activation are made on locally established protocols and defined threshold criteria such as the patient at risk-score. Predictions are made as categorical variable, either MET and/or ECC activation happen, or not (yes/no).
Measured: 2024-10-01 to 2026-10-31
Prediction of Unplanned Intensive Care Unit (ICU) Admission
Intensive care unit (ICU) admission may happen in direct referral from a general ward, via MET referral or after ECC treatment. In either case, this variable will be predicted as a category, i. e. yes/no on ICU admission. An admission in an emergency due to deterioration is always considered unplanned.
Measured: 2024-10-01 to 2026-10-31
Prediction of Electrocardiogram (ECG) Waveform
Future values of the electrocardiogram (ECG) waveform (millivolts at specific point in time) are predicted.
Measured: 2024-10-01 to 2026-10-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RISC Software GmbH, innovethic eU, FiveSquare GmbH
- Responsible party
- Sponsor
- Investigators
- Thomas Tschoellitsch, MD, Principal investigator, Johannes Kepler University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574906
- Sponsor's protocol ID
- AIM-PEW-WAR
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Prediction of Parameters of Early Warning Scores in General Wards
- ClinicalTrials.gov ID
- NCT06574906
- Acronym / sponsor ID
- AIM-PEW-WAR
- Conditions
- Patient Safety
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Collaborators
- RISC Software GmbH, innovethic eU, FiveSquare GmbH
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Aug 2024 (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.
In the event of illness or injury, patients are medically evaluated and initially treated in acute medical outpatient clinics, emergency rooms and surgeries. If medically indicated, care and treatment can also be provided in hospital. Depending on the severity of the illness and the main medical problem, this care is provided on hospital wards, which are primarily looked after by specific specialist disciplines and assigned to them in the form of clinical departments, for example.
As part of the inpatient stay, treatment and care is usually provided through ward rounds by the medical staff. However, ward rounds are spot checks of individual measured values at predefined times.
Qualified nursing staff carry out the agreed treatment plans and check the patient's general condition several times a day. In contrast to intensive medical monitoring, however, there is no continuous monitoring and therefore an aggravation of a patient's condition is not always immediately apparent. Furthermore, in addition to known complications of existing conditions, new or unexpected complications can also occur.
Although non-intensive care monitoring is based on discontinuous monitoring, incidents and complications can sometimes be life-threatening, especially if there is no immediate response to a deterioration in the patient's condition. Even if there are early warning systems such as scores, their ability to react is limited, partly due to the frequency with which they are collected.
In addition to patient-specific limitations of inpatient monitoring, such as patient cooperation in the sense of self-monitoring, medical limitations, such as the frequency of the survey, there are also economic limitations, such as the availability of staff who can be deployed for more frequent monitoring.
Although there are telemedical approaches to monitoring, setting these up is often limited both economically and by the additional training required, for example.
Even if threshold values are (or can be) defined for the measured data (vital signs, laboratory parameters, clinical impression and others), if these are exceeded or not reached, a consequence, e.g. a therapy step, can only be initiated retrospectively. In this situation, a pathophysiological change is already so far advanced that in many cases a compensation mechanism no longer functions adequately and turns into a decompensation situation. In this situation, the affected patients in a hospital ward are potentially in mortal danger.
One way of averting the dangers described above could be to use a reduced combination of monitoring methods compared to intensive care monitoring. At the same time, the use of artificial intelligence enables the automated evaluation of the collected data and can thus lead to the prediction of changes in parameters, which enables early alerting, i.e. before the occurrence of pathophysiological decompensation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in general wards.
Key inclusion criteria (1 listed)
- Treated in general ward between 2024-10-01 and 2026-10-31 at the study center.
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 |
|---|---|---|
| Parameters of Early Warning ScoresParameters of Early Warning Scores | Other | – |
Primary outcome
Area Under the Curve of the Receiver Operating Characteristic (AUC-ROC) for Prediction of Parameters of Early Warning Scores
Time frame: 2024-10-01 to 2026-10-31
Area Under the Curve of the Receiver Operating Characteristic (AUC-ROC) for Prediction of Parameters of Early Warning Scores
Area Under the Curve of the Precision-Recall Curve (AUC-PRC) for Prediction of Parameters of Early Warning Scores
Time frame: 2024-10-01 to 2026-10-31
Area Under the Curve of the Precision-Recall Curve (AUC-PRC) for Prediction of Parameters of Early Warning Scores
F-Beta Score with Beta = 1 (F1-Score) for Prediction of Parameters of Early Warning Scores
Time frame: 2024-10-01 to 2026-10-31
F-Beta Score with Beta = 1 (F1-Score) for Prediction of Parameters of Early Warning Scores
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Time frame: 2024-10-01 to 2026-10-31
Confusion Matrix for Prediction of Parameters of Early Warning Scores
6 secondary outcomes
SHapley's Additive exPlanations (SHAP) Values for Prediction Models
Time frame: 2024-10-01 to 2026-10-31
Prediction of Routine Laboratory Values
Time frame: 2024-10-01 to 2026-10-31
Prediction of Parameters Measured by Photophlethysmogram (PPG)
Time frame: 2024-10-01 to 2026-10-31
Prediction of Medical Emergency Team or Emergency Critical Care Treatment
Time frame: 2024-10-01 to 2026-10-31
Prediction of Unplanned Intensive Care Unit (ICU) Admission
Time frame: 2024-10-01 to 2026-10-31
Prediction of Electrocardiogram (ECG) Waveform
Time frame: 2024-10-01 to 2026-10-31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Thomas Tschoellitsch, MD principal investigator
Johannes Kepler University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by Kepler University Hospital at 1 site in Austria.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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 Austria. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the Curve of the Receiver Operating Characteristic (AUC-ROC) for Prediction of Parameters of Early Warning Scores (time frame: 2024-10-01 to 2026-10-31). The study lists 4 primary outcomes in all. 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 3 Sep 2025.