Machine Learning Prediction of Mortality After Prone Positioning in ARDS

March 1, 2026 updated by: Shanghai Zhongshan Hospital

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

Study Type

Observational

Enrollment (Estimated)

377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation in the intensive care unit at Zhongshan Hospital, Fudan University. Clinical data were collected retrospectively from electronic medical records.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • B2026-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to institutional and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on ARDS

Clinical Trials on Prone Position Ventilation

Subscribe