Status:
NOT_YET_RECRUITING
Multimodal Database and Large Language Model for ARDS
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Respiratory Distress Syndrome, Acute
Severe Community-Acquired Pneumonia
Eligibility:
All Genders
18+ years
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), the...
Detailed Description
ARDS is a common critical illness in ICUs with high mortality rates. Its prognostic factors are complex and multifaceted, including challenges in precise early warning, lack of early diagnostic biomar...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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):
- Major Criteria:
- Requires mechanical ventilation (intubation).
- Septic shock requiring vasopressors after fluid resuscitation.
- Minor Criteria:
- Respiratory rate ≥30 breaths/min.
- PaO₂/FiO₂ ≤250 mmHg.
- Multilobar infiltrates.
- Altered mental status/disorientation.
- BUN ≥20 mg/dL (7.12 mmol/L).
- Leukopenia (WBC \<4×10⁹/L).
- Thrombocytopenia (platelets \<100×10⁹/L).
- Hypothermia (core temp \<36°C).
- SBP \<90 mmHg requiring aggressive fluid resuscitation.
- ( 4 ) Signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
May 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
6500 Patients enrolled
Trial Details
Trial ID
NCT06973733
Start Date
May 7 2025
End Date
March 31 2028
Last Update
May 15 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.