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CompletedNCT06213779Updated Apr 28, 2026

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

An observational study in Acute Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by Southeast University, China. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Southeast University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,032
Ages
18 Years and older
Sex
All
01

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.
Read the detailed 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.
02

Conditions studied

  • Acute Respiratory Failure
  • Acute Respiratory Distress Syndrome
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 4,032 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort of patients receiving respiratory support.

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

Exclusion Criteria:

  • Age\<18.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,032 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • One group

    This is a prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.

06

What researchers measure

Primary outcomes

  1. Development of ARDS with new global definition

    Time frame: 28-days

Secondary outcomes

  1. ICU mortality

    Time frame: 28-days

07

Study locations

2 sites
  • China-Japan friendship hospital
    Beijin, China
  • Zhongda Hospital, Southeast university
    Nanjing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06213779
Lead sponsor
Southeast University, China
Responsible party
Ling Liu (Professor, Southeast University, China) — Principal investigator
First posted
Jan 19, 2024
Start date
Jan 1, 2024
Primary completion
Apr 30, 2024
Completion
Oct 31, 2024
Last update
Apr 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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