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OpenTrials
Completed

NCT Number: NCT05471193

Prediction of Cardiac Instability in Intensive Care

A large number of different organ functions are recorded in real time for patients who are monitored in an intensive care unit. On the one hand, the measured values collected in this way are used for continuous monitoring of vital parameters, but they are also evaluated several times a day in order to be able to make decisions regarding further diagnostics and therapy. In the first case, threshold values can be defined, and if these are exceeded or fallen short of, the treatment team is automatically alerted. If these limits are set too liberally, then the alert will only indicate an acute risk to the patient, where extensive pathophysiological changes have already occurred. If the limits are chosen too restrictively, then there are frequent false alarms, since the limits are exceeded in most cases due to natural fluctuation, without this having any pathological value. The consequence is a so-called "alarm fatigue", which in the worst case leads to ignoring correct alarms and thus endangers the patients. By design, all of these readings only show the status quo of a patient. It is the task of the treatment team to predict from the course of these readings whether a threatening situation is developing for the patient.

For daily clinical practice, it would be better if dangerous changes in vital signs could be predicted. In this case, it would be possible to intervene therapeutically not only when a dangerous situation has arisen, but to try to avert this situation through adequate measures by changing the therapy strategy. In such a case, the treatment team would no longer be confronted with emergency alarms, but could counteract an impending deterioration with a long lead time.

The first approaches for detecting a drop in blood pressure, for example, which are based on simple models, are already in clinical use.

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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, 4021, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adult patients that have been treated at the intensive care units of the Kepler University Hospital, Linz, Austria between 2018-03-01 and 2020-10-31.

Exclusion criteria

  • None.

Treatment and study plan

Machine Learning Prediction

Diagnostic Test

Machine Learning Prediction

Primary outcomes

  1. AUROC for Classification of Instability

    Time frame: 2018-03-01 to 2020-10-31

    AUROC for Classification of Instability

Secondary outcomes

  1. Confusion Matrix

    Time frame: 2018-03-01 to 2020-10-31

    Confusion Matrix Results: true positives, true negatives, false positive, false negatives and values calculated from these results.

  2. Descriptive Statistics This outcome measure will compare the individual feature (e. g. height in cm) in one group vs. the other. Significant difference will be described by p-value.

    Time frame: 2018-03-01 to 2020-10-31

    Descriptive Statistics (age in years, height in cm, weight in kg, gender as male/female, date of death, standard laboratory measurements (e. g. blood gas analysis, full blood count, liver function tests, kidney function tests), ICD 10-codes associated with the patient's admission, Glasgow Coma Scale)

    This outcome measure will compare the individual feature (e. g. height in cm) in one group vs. the other. Significant difference will be described by p-value.

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Acronym: PRECAIN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2022
Registry last updated
Aug 17, 2022

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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