- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445061
Machine Learning Prediction of Mortality After Prone Positioning in ARDS
A Machine Learning Model to Predict Mortality in Patients With Acute Respiratory Distress Syndrome After Prone Positioning
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Early identification of patients at high risk of mortality after PPV may improve clinical decision-making and individualized management.
This retrospective observational study aims to develop and validate a machine learning model to predict intensive care unit (ICU) mortality in ARDS patients receiving prone position ventilation. Clinical, laboratory, and treatment variables collected from ICU electronic medical records will be used to construct prediction models using multiple machine learning algorithms. The performance of these models will be evaluated and compared to identify the optimal model for mortality prediction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of ARDS according to the Berlin definition [15];
- Receipt of at least one session of prone position ventilation (PPV) during hospitalization;
- Requirement for mechanical ventilation.
Exclusion Criteria:
- Age <18 years;
- PPV duration <6 hours;
- ICU length of stay <24 hours;
- Pregnancy;
- Missing key clinical data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ARDS Patients Receiving Prone Position Ventilation
Adult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation during intensive care unit (ICU) admission.
Clinical data from electronic medical records will be collected retrospectively for the development and validation of machine learning models to predict ICU mortality.
|
Prone position ventilation applied as part of routine clinical care for patients with acute respiratory distress syndrome.
No experimental intervention was assigned in this observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Mortality
Time Frame: Up to 90 days.
|
Death from any cause during the intensive care unit (ICU) stay among patients with acute respiratory distress syndrome receiving prone position ventilation.
|
Up to 90 days.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ARDS subphenotype classification based on machine learning model.
Time Frame: Baseline (at initiation of prone position ventilation).
|
Number of patients classified into different ARDS subphenotypes using a machine learning model based on clinical and physiological variables collected at baseline.
|
Baseline (at initiation of prone position ventilation).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2026-019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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