Pressure InjuryICUNCT07306143
Prediction of Pressure Injury Risk in ICU Using Data Mining
An observational study of Pressure Injury, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- How many people
- 500 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Jan 2026to 29 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years and older who were hospitalized in the intensive care unit (ICU) of a tertiary public hospital between October 10, 2020, and October 10, 2025 will be included in this retrospective observational study. The study population includes patients with a minimum ICU stay of 24 hours and complete, accessible electronic or paper-based medical records. Patients with missing or inconsistent medical record data or with a pressure injury diagnosed before or at the time of ICU admission will be excluded. All data will be collected retrospectively from existing medical records.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bolu Izzet Baysal State Hospital
Bolu, Bolu, 14100
Bolu Izzet Baysal State Hospital
Merkez, Bolu, 14100
About this study
Official title: Prediction of Pressure Injury Risk in the Intensive Care Unit: A Comparative Analysis of Data Mining Algorithms in a Single-Center Retrospective Cohort
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.
Read the 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.
- Conditions
- Pressure Injury
- Being tested
- No intervention
- Keywords
- Pressure injury risk, Data mining, Machine learning, Retrospective study, Risk prediction
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a retrospective observational study. No interventions will be applied. All data will be obtained from existing medical records.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction accuracy of pressure injury development
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.
Measured: 10 October 2020 to 10 October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start16 Jan 2026
- Primary completion1 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
- Investigators
- Saadet Can Çiçek, Assoc. Prof., PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306143
- Sponsor's protocol ID
- AIBU-SBF-NSY-2025
- Acronym
- ICU
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study uses retrospective clinical records that contain sensitive personal health information. In accordance with institutional policies, ethical committee approval, and national data protection regulations (KVKK), IPD cannot be made publicly available. Only aggregated and de-identified results will be provided in publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pressure Injury Risk in the Intensive Care Unit: A Comparative Analysis of Data Mining Algorithms in a Single-Center Retrospective Cohort
- ClinicalTrials.gov ID
- NCT07306143
- Acronym / sponsor ID
- ICU / AIBU-SBF-NSY-2025
- Conditions
- Pressure Injury
- Keywords
- Pressure injury risk, Data mining, Machine learning, Retrospective study, Risk prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 29 Dec 2025 (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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patient Cohort | – | Other: No interventionAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older who were hospitalized in the intensive care unit (ICU) of a tertiary public hospital between October 10, 2020, and October 10, 2025 will be included in this retrospective observational study. The study population includes patients with a minimum ICU stay of 24 hours and complete, accessible electronic or paper-based medical records. Patients with missing or inconsistent medical record data or with a pressure injury diagnosed before or at the time of ICU admission will be excluded. All data will be collected retrospectively from existing medical records.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| No interventionThis is a retrospective observational study. No interventions will be applied. All data will be obtained from existing medical records. | Other | ICU Patient Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study uses retrospective clinical records that contain sensitive personal health information. In accordance with institutional policies, ethical committee approval, and national data protection regulations (KVKK), IPD cannot be made publicly available. Only aggregated and de-identified results will be provided in publications.
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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.
Saadet Can Çiçek, Assoc. Prof., PhD principal investigator
Abant Izzet Baysal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prediction accuracy of pressure injury development (time frame: 10 October 2020 to 10 October 2025). 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 1 May 2026.