Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome

Detailed Description

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.

Data collection:

1. For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
2. For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
3. For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

• Study Type: Observational
• Enrollment (Actual): 2530

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100730
      • MICU, Peking union medical college hospital
    • Beijing, Beijing, China
      • Beijing Hospital of Ministry of Health
    • Beijing, Beijing, China
      • Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
    • Beijing, Beijing, China
      • General ICU, Beijing Tongren Hospital, Capital Medical University
    • Beijng, Beijing, China
      • China-Japan Friendship Hospital
  • Chongqing
    • ChongQing, Chongqing, China
      • Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Department of CriticalCare Medicine, Guangdong General Hospital
  • Hainan
    • HaiKou, Hainan, China
      • Department of Critical Care Medicine, Hainan Provincial People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • ICU, The First Affiliated Hospital, Zhengzhou University
  • Hubei
    • WuHan, Hubei, China
      • Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
  • Hunan
    • Changsha, Hunan, China
      • Department of Critical Care Medicine, Xiangya Hospital, Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
  • Jilin
    • ChangChun, Jilin, China
      • Department of Critical Care Medicine, The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
  • Ningxia
    • YinChuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China
      • Department of Critical Care Medicine, Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China
      • Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
  • Shanxi
    • XiAn, Shanxi, China
      • Surgical Intensive Care Unit, Xijing Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Department of Critical Care Medicine, West China Hospital, Sichuan University
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Department of Critical Care Medicine, Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )

Description

Inclusion Criteria:

all patients age >18 yrs admitted to 24 participating ICUs

Exclusion Criteria:

No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ARDS, non-ARDS; patients with ARDS and patients without ARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of acute respiratory distress syndrome (ARDS)	incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU	from ICU admission to 28-day of ICU stay

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality of patients with ARDS	followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS	followed up to 3 months after inclusion or to hospital discharge, whichever occurred first

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Bin Du, MICU of Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: MICU2015_1