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This prospective observational study aims to develop and internally validate a machine learning model for the early prediction of hypotension in adult intensive care unit patients. The model will use routinely collected non-invasive vital signs, heart rate, medication-dose records, and fluid-balance data recorded during standard ICU care. No intervention will be assigned by the study, and patient management will not be changed according to the model output. The primary aim is to predict hypotension 30 minutes before its occurrence; shorter 5- and 15-minute prediction horizons will also be evaluated.
Hypotension is a frequent hemodynamic event in critically ill patients and may occur before clear clinical deterioration is recognized. Earlier identification of patients at risk may support closer clinical attention and more timely evaluation. This study is designed as a prospective, observational machine learning study in adult intensive care unit patients.
Routinely available ICU data will be collected at five-minute intervals, including systolic, mean, and diastolic non-invasive blood pressure, heart rate, medication-dose entries, and fluid-balance records. These data will be used to construct time-dependent features reflecting recent values, short-term changes, and rolling trends. Hypotension will be defined at each five-minute time point as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg.
The primary prediction horizon will be 30 minutes. Separate secondary analyses will evaluate 5- and 15-minute prediction horizons. A gradient-boosted decision-tree model will be developed and internally validated using patient-level data partitioning to avoid assigning observations from the same patient to both training and validation sets. Model performance will be assessed using discrimination, classification performance, and calibration measures. Feature-importance analyses will be used to describe the variables contributing to model predictions.
The study is observational. No treatment, medication, device, alarm, or clinical decision will be assigned by the study protocol. The prediction model will be developed and evaluated using collected data and will not be used to guide real-time patient management during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Intensive Care Unit Patients | Adult patients admitted to the intensive care unit who are monitored during routine clinical care. Routinely collected non-invasive blood pressure, heart rate, medication-dose, and fluid-balance data will be used for machine learning model development and internal validation. No treatment or clinical intervention will be assigned by the study protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine ICU Data Collection | Other | Routinely collected intensive care unit data, including non-invasive blood pressure, heart rate, medication-dose records, and fluid-balance data, will be recorded and analyzed for development and internal validation of a machine learning model. The study does not assign any treatment, medication, device, alarm, or clinical decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve for 30-Minute Hypotension Prediction | Discriminative performance of the machine learning model for predicting hypotension 30 minutes before its occurrence. Hypotension will be defined as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg at a five-minute observation point. | From enrollment through the end of ICU monitoring, up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve for 5- and 15-Minute Hypotension Prediction | Discriminative performance of separate machine learning models for predicting hypotension at 5-minute and 15-minute prediction horizons. | From enrollment through the end of ICU monitoring, up to 4 months |
| Classification Performance of the Hypotension Prediction Model |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of consecutive adult patients monitored in the adult intensive care unit of Kutahya Health Sciences University during the study period. Routine clinical monitoring data, including non-invasive blood pressure, heart rate, medication-dose records, and fluid-balance data, will be used for machine learning model development and internal validation. No treatment or intervention will be assigned by the study protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya City Hospital | Kütahya | Kütahya | 43100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Classification performance of the machine learning model will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and F1 score at predefined classification thresholds. |
| From enrollment through the end of ICU monitoring, up to 4 months |