NCT06213779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,032

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 9, 2024

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Development of ARDS with new global definition

    28-days

Secondary Outcomes (1)

  • ICU mortality

    28-days

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Age\<18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China-Japan friendship hospital

Beijin, China

Location

Zhongda Hospital, Southeast university

Nanjing, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 19, 2024

Study Start

January 1, 2024

Primary Completion

April 30, 2024

Study Completion

October 31, 2024

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations