Machine Learning Prediction of Mortality After Prone Positioning in ARDS

NCT07445061 | Completed

• 1 other identifier: B2026-019
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

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 developed and validated a machine learning model to predict intensive care unit (ICU) mortality in patients with ARDS receiving prone position ventilation. Clinical, laboratory, and treatment variables obtained from ICU electronic medical records were used to construct prediction models using multiple machine learning algorithms. The performance of these models was evaluated and compared to identify the optimal model for mortality prediction.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Prone Position Ventilation; Machine Learning; ICU; ARDS

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  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 Outcomes (1)

• ARDS subphenotype classification based on machine learning model.

  Baseline (at initiation of prone position ventilation).

Study Arms (1)

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 were retrospectively obtained from electronic medical records for the development and validation of machine learning models to predict ICU mortality.

Other: Prone Position Ventilation

Interventions

Prone Position Ventilation OTHER

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.

ARDS Patients Receiving Prone Position Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, between October 2019 and August 2025. Clinical data were retrospectively obtained from electronic medical records.

You may qualify if:

• Diagnosis of ARDS according to the Berlin definition;
• Receipt of at least one session of prone position ventilation (PPV) during hospitalization;
• Requirement for mechanical ventilation.

You may not qualify if:

• Age \<18 years;
• PPV duration \<6 hours;
• ICU length of stay \<2 days;
• Pregnancy;
• Receipt of awake prone positioning.
• Missing key clinical data.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning after publication and for 5 years following publication.
• Access Criteria: Researchers who submit a scientifically sound proposal may request access from the corresponding author. Requests will be reviewed by the study investigators and will be subject to applicable institutional and ethical requirements. A data use agreement may be required.

Locations

CN (1)