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Exploration of Diagnosis and Treatment Strategies and Prognostic Prediction Models for Acute Respiratory Distress Syndrome Based on Radiographic Evaluations Assessed by Artificial Intelligence

Exploration of Diagnosis and Treatment Strategies and Prognostic Prediction Models for Acute Respiratory Distress Syndrome Based on Radiographic Evaluations Assessed by Artificial Intelligence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07328997
Enrollment
400
Registered
2026-01-09
Start date
2024-05-31
Completion date
2025-11-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AI (Artificial Intelligence), ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS, chest CT, AI models

Brief summary

By using multi-center chest CT data, an intelligent assessment model for the severity of ARDS was constructed. Based on CT quantitative features and clinical characteristics, a prediction model for short-term critical events (such as mechanical ventilation decisions, prone position strategies, death, ECMO use, etc.) was established. The disease was staged and quantified, and a diagnosis and risk stratification model for ARDS was developed to assist in guiding the diagnosis and treatment strategies for ARDS.

Interventions

DIAGNOSTIC_TESTCT scan

CT scan

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Meets the diagnostic criteria for ARDS * Be admitted to the intensive care unit * There are chest CT images

Exclusion criteria

* Age less than 18 years old * Missing medical records * No chest CT images

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of ARDS severity classificationBaseline, defined as within 24 hours of index chest CT acquisition during ICU admission.Accuracy of the artificial intelligence-based model in classifying ARDS severity (mild, moderate, or severe), using the reference clinical classification defined by the 2023 global ARDS criteria as the ground truth.
Treatment plan matching rate between model-recommended and actual clinical management.Baseline, defined as within 24 hours of index chest CT acquisition during ICU admission.Concordance rate between model-recommended treatment strategies and actual clinical management decisions across five predefined intervention modalities: mechanical ventilation, high-flow nasal oxygen therapy, non-invasive ventilation, prone positioning, and neuromuscular blockade.
Accuracy of 28-day in-hospital mortality prediction.Up to 28 days from ICU admission, or until hospital discharge, whichever occurs first.Accuracy of the model in predicting all-cause in-hospital mortality within 28 days, based on integrated chest CT imaging features and clinical variables.

Secondary

MeasureTime frameDescription
Comparative performance improvement over baseline AI models.Baseline for severity classification and treatment plan matching; up to 28 days from ICU admission for mortality predictionAbsolute performance improvement of the proposed model compared with three commonly used baseline artificial intelligence models across ARDS severity classification, treatment plan matching, and 28-day mortality prediction.
Association between treatment concordance and 28-day in-hospital mortality.Up to 28 days from ICU admission, or until hospital discharge, whichever occurs first.Association between concordance of model-recommended interventions and actual clinical treatments and 28-day in-hospital mortality, evaluated using multivariable logistic regression adjusted for key imaging-derived structural metrics.
Calibration performance of 28-day mortality prediction.Up to 28 days from ICU admission, or until hospital discharge, whichever occurs first.Calibration of the mortality prediction model assessed using calibration curves and calibration statistics to evaluate agreement between predicted and observed 28-day in-hospital mortality.
Model interpretability based on imaging and clinical feature contributions.Baseline for feature extraction; up to 28 days from ICU admission for outcome association analysis.Quantification of the relative contributions of imaging-derived features and clinical variables to mortality prediction using Shapley Additive Explanations (SHAP). Feature importance will be analyzed overall and stratified by ARDS severity.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026