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Accuracy, Consistency, and Applicability of ARDS Diagnosis: A Bidirectional Cohort Study

Accuracy, Consistency, and Applicability of ARDS Diagnosis: A Bidirectional Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090719
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

Gold Standard:The Berlin Definition of Acute Respiratory Distress Syndrome (ARDS)
Index test:The new global definition of ARDS published online in the American Journal of Respiratory and Critical Care Medicine on May 24, 2023.

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Retrospective study section: 1. Age = 18 years; 2. Diagnosed with ARDS, meeting either the Berlin criteria or the new global criteria; 3. Not intubated, with HFNO = 30 L/min, or under non-invasive ventilation (NIV)/continuous positive airway pressure (CPAP) with PEEP = 5 cmH2O; 4. Hypoxemia: PaO2/FiO2 = 300 mmHg or SpO2/FiO2 = 315 mmHg with SpO2 = 97%; 5. Chest X-ray or CT showing bilateral dense opacities, or ultrasound showing bilateral B-lines and/or consolidation, which cannot be fully explained by pleural effusion, lung lobe collapse/atelectasis, or nodules. Prospective study section: 1. Age = 18 years; 2. Patients admitted to the ICU who are at high risk of developing ARDS.

Exclusion criteria

Exclusion criteria: Retrospective study section: 1. Hospitalization or survival time not exceeding 24 hours; 2. Congestive heart failure; 3. Cardiogenic pulmonary edema; 4. Pulmonary hypertension; 5. Large pleural effusion; 6. Extensive lung lobe collapse/atelectasis; 7. Missing PaO2, FiO2, or SpO2 data; 8. Missing PEEP data; 9. Patients not using high-flow oxygen or NIV/CPAP, and those with more than 30% missing data for variables, were excluded from the variable selection process. Prospective study section: 1. Hospitalization or survival time not exceeding 24 hours; 2. Diagnosed with ARDS upon hospital admission or ICU admission; 3. Presence of severe comorbidities, such as severe heart failure, end-stage COPD, untreated or uncontrolled pulmonary hypertension, or late-stage lung cancer or widely metastatic pulmonary tumors.

Design outcomes

Primary

MeasureTime frame
Accuracy and Consistency;

Secondary

MeasureTime frame
Applicability;

Countries

China

Contacts

Public ContactTian Baoping

The Second Affiliated Hospital of Zhejiang University School of Medicine

tianbp@zju.edu.cn+86 187 6814 0793

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026