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Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome in China RICUs-CHARDS II Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06069466
Enrollment
1000
Registered
2023-10-05
Start date
2023-10-15
Completion date
2025-07-31
Last updated
2023-10-05

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; mortality; incidence; prognosis; predictive model; AI

Brief summary

This project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ARDS patients in RICU. By collecting 1,000 patients, a clinical database related to ARDS in China was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ARDS patients and further clinical intervention research. At the same time, ARDS biobank was established in China-Japan Hospital and Xiangya Hospital to realize the integration of clinical data and sample resources, and the prediction model of ARDS survival and complications of tuberculosis clinical data and biological samples was established by using big data and AI technology.

Interventions

None listed

Sponsors

China-Japan Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* New or worsening respiratory symptoms less than 7 days after the acute blow. * CT/X-ray: Double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule. * Respiratory failure that cannot be explained by heart failure or fluid overload * After 15min assisted ventilation (PEEP or CPAP ≥ 5cmH2O) or HFNC with flow≥30L/min, PaO2/FiO2≤300mmHg * Classification of ARDS: mild (200mmHg \< PaO2/FIO2 ≤ 300mmHg), moderate (100mmHg \< PaO2/FIO2 ≤ 200mmHg), and severe (PaO2/FIO2 ≤ 100mmHg) and 4 ancillary variables for severe ARDS

Exclusion criteria

* younger than 18 years old * Patients or family members refused to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
the prognosis of ARDS patientsfrom 28d to 1 yearICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients

Secondary

MeasureTime frameDescription
Length of hospital stay in ARDS patientsduring hospitalizationLength of hospital stay in ARDS patients
VFDs within 28 days28 daysMechanical ventilation free days within 28 days
Long-term quality of life and long-term lung function1 year3month,6month,1year quality of life score and 1year lung function
Incidence of ARDS in ICUs2 yearsIncidence of ARDS in ICUs
Survival risk factors in hospitalized ARDS patientsduring hospitalizationSurvival risk factors in hospitalized ARDS patients
Risk factors for ARDS complicationsduring hospitalizationRisk factors for ARDS complications(including AKI and barotrauma)
Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelinesduring hospitalizationconsistence of lung protective ventilation strategies(including small tidal volume and limitation of Pplat)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026