Patient SafetyAIM-PEW-ICUNCT06259812
Machine Learning Prediction of Parameters of Early Warning Scores in Intensive Care Units
An observational study of Patient Safety, run by Kepler University Hospital at 1 site in Austria.
Trial summary
A large number of different organ functions are recorded in real time for patients being monitored in an intensive care unit. On the one hand, the measured values collected are used for continuous monitoring of vital parameters, e.g. 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
- 8,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2024to 15 Sep 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated in intensive care.
Who may be able to join
- Treated in intensive care between 2010-01-01 and 2023-12-31 at the study center.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
A large number of different organ functions are recorded in real time for patients being monitored in an intensive care unit. On the one hand, the measured values collected are used for continuous monitoring of vital parameters, e.g. blood pressure, heart rate and respiratory rate, but are also evaluated several times a day in conjunction with other data as part of ward rounds. In both cases, continuous monitoring from a limited number of parameters, but also in the distinct evaluation with a more extensive set of analyzable parameters, there are limitations in the evaluability even with all the care and expertise available: In continuous analysis, interpretation is limited by the restricted number of continuously recorded parameters described above. Although a large number of such measurements are possible, and at least theoretically a larger number of parameters could be measured, patient-specific limits such as patient cooperation, medical limits such as the significance of the measured values in specific situations, but also economic limits are often decisive in this context. Although accurate conclusions can be drawn from the continuous and therefore complete representation of aspects of human physiology, the limitation of the available parameters reduces the interpretability of the synthesis of different statuses. In the broader, more comprehensive assessments during visits at specific points in time, on the other hand, there are limitations due to, among other things, point recordings of individual measured values and the predefined visit times. Even if limit values are (or can be) defined for the measured data, and a consequence, e.g. a therapy step, is initiated if these values are exceeded or not reached, this alert can only be initiated retrospectively if these values are exceeded and a consequence 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 patients affected in an intensive care unit are in many cases in mortal danger. Both situations, continuous recording of a limited number of parameters and the evaluation of extensive data in the form of a snapshot could be optimized despite the limitations mentioned. Without changing the collection of data (time, scope, etc.), the possibilities for optimizing their interpretation and the consequences that can be derived from the interpretation remain. The interpretation of the data is primarily determined by the interpreters as the method of interpretation. Current approaches attempt to use machine learning (ML) methods to predict individual situations that recognize adverse events in the given data and at the same time allow alarms to be triggered pre-emptively, i.e. before a life-threatening situation occurs. Furthermore, there are already studies on the change of early warning scores in time series, which are, however, limited in their informative value for longer prediction periods.
- 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.
AUC-ROC for Prediction of Parameters of Early Warning Scores
AUC-ROC for Prediction of Parameters of Early Warning Scores
Measured: 2010-01-01 to 2023-12-31
AUC-PRC for Prediction of Parameters of Early Warning Scores
AUC-PRC for Prediction of Parameters of Early Warning Scores
Measured: 2010-01-01 to 2023-12-31
F1-Score for Prediction of Parameters of Early Warning Scores
F1-Score for Prediction of Parameters of Early Warning Scores
Measured: 2010-01-01 to 2023-12-31
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Measured: 2010-01-01 to 2023-12-31
Secondary outcomes (2)
SHAP Values for Prediction Models
SHAP Values for Prediction Models
Measured: 2010-01-01 to 2023-12-31
Confusion Matrix for Prediction of In Hospital-Mortality
Confusion Matrix for Prediction of In Hospital-Mortality
Measured: 2010-01-01 to 2023-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 May 2024
- Primary completion15 Sep 2024
- Study completion15 Sep 2025 (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
- Retrospective
- Enrolment
- 8,000 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
- Jens Meier, MD, Study chair, Johannes Kepler University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259812
- Sponsor's protocol ID
- AIM-PEW-ICU
- Acronym
- AIM-PEW-ICU
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. 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 Intensive Care Units
- ClinicalTrials.gov ID
- NCT06259812
- Acronym / sponsor ID
- AIM-PEW-ICU / AIM-PEW-ICU
- Conditions
- Patient Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Collaborators
- RISC Software GmbH, innovethic eU, FiveSquare GmbH
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 14 Feb 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.
A large number of different organ functions are recorded in real time for patients being monitored in an intensive care unit. On the one hand, the measured values collected are used for continuous monitoring of vital parameters, e.g. blood pressure, heart rate and respiratory rate, but are also evaluated several times a day in conjunction with other data as part of ward rounds. In both cases, continuous monitoring from a limited number of parameters, but also in the distinct evaluation with a more extensive set of analyzable parameters, there are limitations in the evaluability even with all the care and expertise available: In continuous analysis, interpretation is limited by the restricted number of continuously recorded parameters described above. Although a large number of such measurements are possible, and at least theoretically a larger number of parameters could be measured, patient-specific limits such as patient cooperation, medical limits such as the significance of the measured values in specific situations, but also economic limits are often decisive in this context. Although accurate conclusions can be drawn from the continuous and therefore complete representation of aspects of human physiology, the limitation of the available parameters reduces the interpretability of the synthesis of different statuses. In the broader, more comprehensive assessments during visits at specific points in time, on the other hand, there are limitations due to, among other things, point recordings of individual measured values and the predefined visit times. Even if limit values are (or can be) defined for the measured data, and a consequence, e.g. a therapy step, is initiated if these values are exceeded or not reached, this alert can only be initiated retrospectively if these values are exceeded and a consequence 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 patients affected in an intensive care unit are in many cases in mortal danger. Both situations, continuous recording of a limited number of parameters and the evaluation of extensive data in the form of a snapshot could be optimized despite the limitations mentioned. Without changing the collection of data (time, scope, etc.), the possibilities for optimizing their interpretation and the consequences that can be derived from the interpretation remain. The interpretation of the data is primarily determined by the interpreters as the method of interpretation. Current approaches attempt to use machine learning (ML) methods to predict individual situations that recognize adverse events in the given data and at the same time allow alarms to be triggered pre-emptively, i.e. before a life-threatening situation occurs. Furthermore, there are already studies on the change of early warning scores in time series, which are, however, limited in their informative value for longer prediction periods.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in intensive care.
Key inclusion criteria (1 listed)
- Treated in intensive care between 2010-01-01 and 2023-12-31 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
AUC-ROC for Prediction of Parameters of Early Warning Scores
Time frame: 2010-01-01 to 2023-12-31
AUC-ROC for Prediction of Parameters of Early Warning Scores
AUC-PRC for Prediction of Parameters of Early Warning Scores
Time frame: 2010-01-01 to 2023-12-31
AUC-PRC for Prediction of Parameters of Early Warning Scores
F1-Score for Prediction of Parameters of Early Warning Scores
Time frame: 2010-01-01 to 2023-12-31
F1-Score for Prediction of Parameters of Early Warning Scores
Confusion Matrix for Prediction of Parameters of Early Warning Scores
Time frame: 2010-01-01 to 2023-12-31
Confusion Matrix for Prediction of Parameters of Early Warning Scores
2 secondary outcomes
SHAP Values for Prediction Models
Time frame: 2010-01-01 to 2023-12-31
Confusion Matrix for Prediction of In Hospital-Mortality
Time frame: 2010-01-01 to 2023-12-31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
Jens Meier, MD study chair
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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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?
Results are not available in the source record.
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?
AUC-ROC for Prediction of Parameters of Early Warning Scores (time frame: 2010-01-01 to 2023-12-31). 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 15 Oct 2024.