Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT06069466
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Study Start: 2023-10-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the prognosis of ARDS patients	from 28d to 1 year	ICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients

Secondary Outcome Measures

Name	Time	Method
Incidence of ARDS in ICUs	2 years	Incidence of ARDS in ICUs
Length of hospital stay in ARDS patients	during hospitalization	Length of hospital stay in ARDS patients
VFDs within 28 days	28 days	Mechanical ventilation free days within 28 days
Long-term quality of life and long-term lung function	1 year	3month，6month，1year quality of life score and 1year lung function
Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines	during hospitalization	consistence of lung protective ventilation strategies（including small tidal volume and limitation of Pplat）
Survival risk factors in hospitalized ARDS patients	during hospitalization	Survival risk factors in hospitalized ARDS patients
Risk factors for ARDS complications	during hospitalization	Risk factors for ARDS complications（including AKI and barotrauma）

Trial Locations

Locations (1)

Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China