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NCT Number: NCT06259812

Machine Learning Prediction of Parameters of Early Warning Scores in Intensive Care Units

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treated in intensive care between 2010-01-01 and 2023-12-31 at the study center.

Exclusion criteria

  • None.

Treatment and study plan

Parameters of Early Warning Scores

Other

Parameters of Early Warning Scores

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. SHAP Values for Prediction Models

    Time frame: 2010-01-01 to 2023-12-31

    SHAP Values for Prediction Models

  2. Confusion Matrix for Prediction of In Hospital-Mortality

    Time frame: 2010-01-01 to 2023-12-31

    Confusion Matrix for Prediction of In Hospital-Mortality

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Collaborators

  • FiveSquare GmbH
  • RISC Software GmbH
  • innovethic eU

Registry information

Acronym: AIM-PEW-ICU

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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