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NCT06973733

Multimodal Database and Large Language Model for ARDS

Sponsor: China-Japan Friendship Hospital

View on ClinicalTrials.gov

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?

Official title: Construction of ARDS Clinical Multimodal Database and ARDS-Specific Large Language Model

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6500

Start Date

2025-05-07

Completion Date

2028-03-31

Last Updated

2025-05-15

Healthy Volunteers

Conditions

Respiratory Distress Syndrome, Acute Severe Community-Acquired Pneumonia

Interventions

BEHAVIORAL

Clinical data and biospecimen collection

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.

Inclusion Criteria: 1\. 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: 1. 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. 2. Timing:Acute onset or worsening of hypoxemic respiratory failure within 7 days of risk factor exposure or new/worsening respiratory symptoms. 3. 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. 4. Oxygenation Status: 1. 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. 2. 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%). 3. Resource-limited settings:No PEEP/minimum oxygen flow required; SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%). ( 4 ) Signed informed consent. 2\. 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): 1. Major Criteria: 1. Requires mechanical ventilation (intubation). 2. Septic shock requiring vasopressors after fluid resuscitation. 2. Minor Criteria: 1. Respiratory rate ≥30 breaths/min. 2. PaO₂/FiO₂ ≤250 mmHg. 3. Multilobar infiltrates. 4. Altered mental status/disorientation. 5. BUN ≥20 mg/dL (7.12 mmol/L). 6. Leukopenia (WBC \<4×10⁹/L). 7. Thrombocytopenia (platelets \<100×10⁹/L). 8. Hypothermia (core temp \<36°C). 9. SBP \<90 mmHg requiring aggressive fluid resuscitation. ( 4 ) Signed informed consent. Exclusion Criteria: 1. Patients without ARDS or ARDS high-risk factors. 2. Age \<18 years. 3. Incomplete clinical data. 4. Refusal to sign informed consent. 5. Long-term nursing home residents. 6. Tracheostomy patients. 7. Currently enrolled in another clinical trial.