The Burden of Acute Respiratory Failure in Chinese ICUs: a National Cohort Study

Last updated: January 24, 2024
Sponsor: Southeast University, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

N/A

Clinical Study ID

NCT06213779
Chi-ARDS
  • Ages > 18
  • All Genders

Study Summary

We aim to prospectively assess the burden, management and therapeutic approaches and outcomes of acute respiratory failure requiring respiratory support, during the winter months in China.

The purpose of this study is to provide new and current data on the disease burden of acute respiratory failure and ARDS. It will answer the following questions:

  • The frequency and disease burden of acute respiratory failure in China;

  • The incidence of ARDS based on the new global definition within this patient cohort.

  • The mortality of ARDS within this cohort, and how does this vary based on ARDS categories and severity.

  • The long-term outcomes (1-year mortality and survivor quality of life) of ARDS within this cohort.

  • The nature course of ARDS (different stages and severity of ARDS).

  • The respiratory support management strategies, such as recruitment maneuvers, prone positioning, ECCO2R, and ECMO.

  • The use of drugs during ICU stays, including glucocorticoid, anticoagulant, nitric oxide, sivelestat, Xuebijing, and ulinastatin.

  • The economical burden of acute respiratory failure within this patient cohort.

  • The impact of occupation, incomes and education levels on the incidence and mortality of ARDS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients admitted to the participating ICU receiving invasive, non-invasiveventilation or high-flow nasal cannula (HFNC) will be screened and included in thedatabase.

Exclusion

Exclusion Criteria:

  • Age<18.

Study Design

Total Participants: 1500
Study Start date:
January 01, 2024
Estimated Completion Date:
April 30, 2025

Study Description

  1. The goal of this study will focus on the following items:

    -  The frequency and disease burden of acute respiratory failure in China;
    
    -  The incidence of ARDS based on the new global definition within this patient
       cohort.
    
    -  The mortality of ARDS within this cohort, and how does this vary based on ARDS
       categories and severity.
    
    -  The long-term outcomes (1-year mortality and survivor quality of life) of ARDS
       within this cohort.
    
    -  The nature course of ARDS (different stages and severity of ARDS).
    
    -  The respiratory support management strategies, such as recruitment maneuvers, prone
       positioning, ECCO2R, and ECMO.
    
    -  The use of drugs during ICU stays, including glucocorticoid, anticoagulant, nitric
       oxide, sivelestat, Xuebijing, and ulinastatin.
    
    -  The economical burden of acute respiratory failure within this patient cohort.
    
    -  The impact of occupation, incomes and education levels on the incidence and
       mortality of ARDS.
    
  2. Methods 2.1 Study Design This is a national prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs in China. Each ICU will be requested to recruit for 8 consecutive 'winter' weeks between January 2024 and April 2024.

    2.2 Inclusion and exclusion criteria

    • Inclusion criteria: All patients admitted to the participating ICU receiving invasive, non-invasive ventilation or high-flow nasal cannula (HFNC) will be screened and included in the database.

    • Exclusion criteria:Age<18

  3. Sample size calculation Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort.

Connect with a study center

  • China-Japan friendship hospital

    Beijin,
    China

    Active - Recruiting

  • Zhongda Hospital, Southeast university

    Nanjing,
    China

    Active - Recruiting

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