A Realworld Study of Acute Respiratory Distress Syndrome in China
- Conditions
- Acute Respiratory Distress Syndrome
- Registration Number
- NCT02975908
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- ≥18 years of age; hospitalized patients with main diagnosis as ARDS.
- <18 years of age
- Patients or their families refused to participate in the study
- Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 28days the 28days mortality after the diagnosis of ARDS
- Secondary Outcome Measures
Name Time Method Incidence of ARDS 2 years The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.
Number of patients with high risk factors 1 week 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.
Length of ICU stay 90 days The days between admission to intensive care unit(ICU) and discharge from ICU.
Ventilation free days 28 days The days between successful weaning from mechanical ventilation and day 28 after study enrollment.
Number of patients using adjuvant drugs 28 days Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.
Number of patients with impaired lung function 90 days, 1 year The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Severity of patients 2 years 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.
Number of patients with conventional respiratory support techniques 28 days Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .
Adverse events related to treatment 90 days Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.
Number of patients with unconventional respiratory support techniques 28 days 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)
Number of patients with abnormal lung CT 90 days, 1 year The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Trial Locations
- Locations (1)
China - Japan Friendship Hospital
🇨🇳Beijing, Beijing, China