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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213779
• Other study ID #: Chi-ARDS
• Status: Recruiting
• Start date: January 2024
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Southeast University, China
• Contact: Ling Liu, PhD
• Phone: +86-02583262550
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Locations

Country	Name	City	State
China	China-Japan friendship hospital	Beijin
China	Zhongda Hospital, Southeast university	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of ARDS with new global definition		28-days
Secondary	ICU mortality		28-days