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

NCT ID: NCT07328997

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Training group, testing group, validation group

The study adopts a stratified random sampling strategy with an 8:2 split to construct training and internal validation datasets, together with an independent external test cohort from a separate center. No randomization of clinical interventions or treatments is involved. The model will be developed and evaluated using observational data derived from real-world clinical pathways and outcomes, with the objectives of assessing performance in disease severity stratification, treatment recommendation, and mortality prediction. Model performance will be compared with established ICU severity scores and existing AI-based approaches according to a prespecified statistical analysis plan.

CT scan

Intervention Type DIAGNOSTIC_TEST

CT scan

Interventions

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CT scan

CT scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of critical care medicine, Zhongshan Hospital, Fudan University

Shanghai, Fengling Rd, China

Site Status

Countries

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China

References

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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B2024-180

Identifier Type: -

Identifier Source: org_study_id

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