A Realworld Study of Acute Respiratory Distress Syndrome in China

Study Overview
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Brief Summary
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ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion has been put forward. Yet, its feasibility, reliability and validity need to be tested. Meanwhile, the correlation of different severity and prognosis remains unclear. As so far, the epidemiological information about ARDS in China is lacking. Investigators plan to conduct a multi-center observational study（real-life study） to investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order to facilitate standardization of diagnosis and management of ARDS and provide basic data and idea for further clinical intervention studies.

Official Title
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A Realworld Study of Acute Respiratory Distress Syndrome in China

Conditions
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Acute Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age; hospitalized patients with main diagnosis as ARDS. Exclusion Criteria: <18 years of age Patients or their families refused to participate in the study Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | the 28days mortality after the diagnosis of ARDS | 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay | The days between admission to intensive care unit(ICU) and discharge from ICU. | 90 days | 
| Ventilation free days | The days between successful weaning from mechanical ventilation and day 28 after study enrollment. | 28 days | 
| Incidence of ARDS | The total number of acute respiratory distress syndrome(ARDS)patients in 2 years. | 2 years | 
| Severity of patients | Number of patients in each grade of severities according to Berlin definition: the number of mild, moderate and severe acute respiratory distress syndrome(ARDS) patients will be recorded. | 2 years | 
| Adverse events related to treatment | Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc. | 90 days | 
| Number of patients using adjuvant drugs | Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant. | 28 days | 
| Number of patients with high risk factors | High risk factors for acute respiratory distress syndrome(ARDS), including endogenous factors as pneumonia, aspiration, lung contusion and drowning; the exogenous factors as extrapulmonary trauma, extra pulmonary sepsis , hypovolemic shock, pancreatitis, severe burning, drug overdose, blood transfusion，eclampsia etc. | 1 week | 
| Number of patients with conventional respiratory support techniques | Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) . | 28 days | 
| Number of patients with unconventional respiratory support techniques | Unconventional respiratory support techniques include recruitment maneuver(RM), prone position ventilation(PPV), high-frequency oscillatory ventilation(HFOV) ,extracorporeal membrane oxygenation(ECMO) and extracorporeal CO2 removal(ECCO2R) | 28 days | 
| Number of patients with impaired lung function | The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS). | 90 days, 1 year | 
| Number of patients with abnormal lung CT | The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS). | 90 days, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome, epidemiology, clinical features, management, prognosis