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

A Multicentre, Prospective, Observational, 8-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of China

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06213779
Enrollment
4032
Registered
2024-01-19
Start date
2024-01-01
Completion date
2024-10-31
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Respiratory Failure

Brief 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.

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.

Interventions

None listed

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Development of ARDS with new global definition28-days

Secondary

MeasureTime frame
ICU mortality28-days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026