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Clinical Trials/NCT07306143
NCT07306143Active, not recruitingNot Applicable

Prediction of Pressure Injury Risk in the Intensive Care Unit: A Comparative Analysis of Data Mining Algorithms in a Single-Center Retrospective Cohort

Abant Izzet Baysal University2 sites in 1 country500 target enrollmentStarted: January 16, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
500
Locations
2
Primary Endpoint
Prediction accuracy of pressure injury development

Study Overview

Brief Summary

This study is a retrospective record review conducted among adult patients hospitalized in the intensive care unit of a tertiary hospital between October 10, 2020, and October 10, 2025. The aim of the study is to predict the risk of pressure injury development using demographic, clinical, laboratory, and nursing care-related variables by applying multiple data mining algorithms. No intervention, treatment, or patient contact will occur. All data will be extracted from existing electronic and paper-based medical records and will be fully anonymized prior to analysis. The study poses no risk to participants and will be conducted with approval from the institutional review board or ethics committee.

Detailed Description

This observational study uses a retrospective cohort design to analyze the clinical, demographic, laboratory, and nursing documentation records of adult intensive care unit (ICU) patients hospitalized between October 10, 2020, and October 10, 2025. The purpose of the study is to identify factors associated with the development of pressure injury and to compare the predictive performance of multiple data mining and machine learning algorithms, including logistic regression, decision trees, random forest, support vector machines, and gradient boosting models.

Data collection will involve reviewing archived ICU records, patient files, and nursing observation forms. No new data will be collected directly from patients, and no medical interventions or prospective follow-up will be performed. All extracted data will be fully anonymized prior to analysis. The study will be conducted in accordance with ethical principles and has been approved by the Bolu Abant Izzet Baysal University Non-Interventional Clinical Research Ethics Committee.

The expected outcome of this study is to identify the most accurate predictive model for pressure injury risk and to support clinical decision-making processes by contributing to early prevention strategies in the ICU.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients hospitalized in the intensive care unit between October 10, 2020, and * October 10, 2025
  • Adult patients aged 18 years and older
  • Length of intensive care unit stay of at least 24 hours
  • Availability of complete and accessible electronic or paper-based medical records

Exclusion Criteria

  • Patients younger than 18 years
  • Intensive care unit stay shorter than 24 hours Incomplete, missing, or inconsistent electronic or paper-based medical records
  • Presence of a pressure injury diagnosed before or at the time of intensive care unit admission
  • Inability to extract pressure injury-related data from medical records

Arms & Interventions

ICU Patient Cohort

Adult patients who will be hospitalized in the intensive care unit between October 10, 2020 and October 10, 2025. No interventions will be applied, and all data will be obtained from existing medical records.

Intervention: No intervention (Other)

Outcomes

Primary Outcomes

Prediction accuracy of pressure injury development

Time Frame: 10 October 2020 to 10 October 2025

The primary outcome is the predictive accuracy of data mining algorithms in identifying the risk of developing pressure injury among patients hospitalized in the intensive care unit (ICU). Accuracy metrics such as the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, precision, recall, and F1-score will be calculated using retrospective medical record data.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saadet Can Çiçek

Associate Professor

Abant Izzet Baysal University

Study Sites (2)

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