Clinical Trial: A Realworld Study of Acute Respiratory Distress Syndrome in China

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: China-Japan Friendship Hospital

Current Primary Outcome: Mortality [ Time Frame: 28days ]

the 28days mortality after the diagnosis of ARDS


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of ICU stay [ Time Frame: 90 days ]
    The days between admission to intensive care unit(ICU) and discharge from ICU.
  • Ventilation free days [ Time Frame: 28 days ]
    The days between successful weaning from mechanical ventilation and day 28 after study enrollment.
  • Incidence of ARDS [ Time Frame: 2 years ]
    The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.
  • Severity of patients [ Time Frame: 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.
  • Adverse events related to treatment [ Time Frame: 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 using adjuvant drugs [ Time Frame: 28 days ]
    Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.
  • Number of patients with high risk factors [ Time Frame: 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.
  • Number of patients with conventional respiratory support techniques [ Time Frame: 28 days ]
    Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .
  • Number of patients with unconventional respiratory support techniques [ Time Frame: 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 impaired lung function [ Time Frame: 90 days, 1 year ]
    The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
  • Number of patients with abnormal lung CT [ Time Frame: 90 days, 1 year ]
    The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).


Original Secondary Outcome: Same as current

Information By: China-Japan Friendship Hospital

Dates:
Date Received: April 5, 2016
Date Started: August 2015
Date Completion: February 2019
Last Updated: November 23, 2016
Last Verified: November 2016