Multimodal Database and Large Language Model for ARDS

NCT06973733 | Not Yet Recruiting

• 1 other identifier: 2024ZD0522702
• Study Type: observational
• Target: 6,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to integrate existing clinical cohorts from the research team to establish dedicated cohorts for ARDS and high-risk ARDS patients (primarily SCAP patients), then systematically collect comprehensive clinical data and multi-omics biological samples to construct a high-quality multimodal ARDS database. Building upon this foundation, the research will develop an ARDS-specific large-scale disease model to assist clinical decision-making in early warning, diagnosis, and prognosis prediction. The main question it seeks to address is: Can the establishment of specialized ARDS cohorts and multimodal databases, combined with the development of an ARDS-specific large-scale disease model, effectively improve ARDS prediction rates, diagnostic accuracy, and reduce mortality rates, thereby enhancing overall clinical management standards?

Conditions

Respiratory Distress Syndrome, Acute; Severe Community-Acquired Pneumonia

Keywords

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• ICU mortality

  From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the time frame would be 20 days.)

• Hospital mortality

  From the time of patient enrollment until hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)

Secondary Outcomes (5)

• ICU length of stay

  From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the observation time frame would be 20 days.)

• Hospital length of stay

  From enrollment to hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)

• Mortality rates at 28 days post-enrollment

  From patient enrollment until 28 days post-enrollment

• Mortality rates at 60 days post-enrollment

  From patient enrollment until 60 days post-enrollment

• Mortality rates at 90 days post-enrollment

  From patient enrollment until 90 days post-enrollment

Study Arms (2)

ARDS

Patients meeting the 2024 global new definition of ARDS.

Behavioral: Clinical data and biospecimen collection

High-risk ARDS patients

Patients admitted to the ICU who do not meet ARDS diagnostic criteria but present with established ARDS risk factors, including: SCAP,, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, and aspiration.The primary etiology in this cohort is SCAP.

Behavioral: Clinical data and biospecimen collection

Interventions

Clinical data and biospecimen collection BEHAVIORAL

Clinical Data Collection: Case report forms were utilized to systematically capture multimodal clinical data, including: demographic characteristics, clinical symptoms and physical signs, laboratory test results, chest imaging data, organ support parameters, pharmacological interventions , complications and clinical outcomes. Biospecimen Collection: ARDS patients underwent biospecimen collection at days 1, 4, and 7 post-diagnosis. High-risk ARDS cohorts provided specimens within 24 hours of ICU admission. Specimens included: peripheral blood, Sputum/BALF, stool and urine.

ARDS; High-risk ARDS patients

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

1. ARDS ptients; 2. ARDS high-risk patients

You may qualify if:

• \. ARDS Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Meets the 2024 Global New Definition of ARDS (diagnosis confirmed by at least two experienced physicians; in case of disagreement, a third physician will adjudicate):Diagnostic Criteria:
• Risk Factors \& Origin of Pulmonary Edema:Acute risk factors (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, shock).
• Pulmonary edema not fully or primarily attributable to cardiogenic pulmonary edema/fluid overload.Hypoxemia/gas exchange abnormalities not primarily due to atelectasis.Exception: ARDS can still be diagnosed if predisposing risk factors exist, even with concurrent conditions.
• Timing:Acute onset or worsening of hypoxemic respiratory failure within 7 days of risk factor exposure or new/worsening respiratory symptoms.
• Chest Imaging (X-ray/CT/US):Bilateral opacities (not fully explained by effusions, atelectasis, or nodules/masses)；Ultrasound findings: Bilateral B-lines and/or consolidations.
• Oxygenation Status:
• Non-intubated ARDS:PaO₂/FiO₂ ≤300 mmHg OR SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%). High-flow nasal oxygen (HFNO) ≥30 L/min or NIV/CPAP ≥5 cm H₂O.
• Intubated ARDS (all enrolled patients assessed via PaO₂/FiO₂):
• Mild: 200 \< PaO₂/FiO₂ ≤300 OR 235 ≤ SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%). Moderate: 100 \< PaO₂/FiO₂ ≤200 OR 148 \< SpO₂/FiO₂ ≤235 (if SpO₂ ≤97%). Severe: PaO₂/FiO₂ ≤100 OR SpO₂/FiO₂ ≤148 (if SpO₂ ≤97%).
• Resource-limited settings:No PEEP/minimum oxygen flow required; SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%).
• ( 4 ) Signed informed consent.
• \. ARDS High-Risk Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Does not meet ARDS criteria at ICU admission but has high-risk factors for ARDS development, including: SCAP, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, aspiration.The primary etiology in this cohort is SCAP.
• SCAP Diagnostic Criteria (≥1 major or ≥3 minor criteria):
• Major Criteria:
• Requires mechanical ventilation (intubation).

You may not qualify if:

• Patients without ARDS or ARDS high-risk factors.
• Age \<18 years.
• Incomplete clinical data.
• Refusal to sign informed consent.
• Long-term nursing home residents.
• Tracheostomy patients.
• Currently enrolled in another clinical trial.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections

Central Study Contacts

Hangyong He

CONTACT

86+13693585722; yonghang2004@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: May 15, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05