Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06973733
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06973733
Study Brief:
Protocol Section:
NCT06973733