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NCT06069466 Clinical Trial

Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06069466
Other study ID # 2023-NHLHCRF-YYPP-TS-04
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 15, 2023
Est. completion date July 31, 2025

Study information
Verified date October 2023
Source China-Japan Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the prognosis of ARDS patients ICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients from 28d to 1 year
Secondary Incidence of ARDS in ICUs Incidence of ARDS in ICUs 2 years
Secondary Length of hospital stay in ARDS patients Length of hospital stay in ARDS patients during hospitalization
Secondary VFDs within 28 days Mechanical ventilation free days within 28 days 28 days
Secondary Long-term quality of life and long-term lung function 3month,6month,1year quality of life score and 1year lung function 1 year
Secondary Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines consistence of lung protective ventilation strategies(including small tidal volume and limitation of Pplat) during hospitalization
Secondary Survival risk factors in hospitalized ARDS patients Survival risk factors in hospitalized ARDS patients during hospitalization
Secondary Risk factors for ARDS complications Risk factors for ARDS complications(including AKI and barotrauma) during hospitalization
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