Acute Respiratory FailureNCT06213779
The Burden of Acute Respiratory Failure in Chinese ICUs: a National Cohort Study
An observational study of Acute Respiratory Failure and Acute Respiratory Distress Syndrome, run by Southeast University, China at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 4,032 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2024to 31 Oct 2024
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort of patients receiving respiratory support.
Who may be able to join
- 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.
Who cannot join
- Age<18.
Trial locations and contacts
2 sites in 1 country.
China2 sites
China-Japan friendship hospital
Beijin
Zhongda Hospital, Southeast university
Nanjing
About this study
Official title: A Multicentre, Prospective, Observational, 8-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of China
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
- 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.
- 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
- Sample size calculation Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort.
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of ARDS with new global definition
Measured: 28-days
Secondary outcomes (1)
ICU mortality
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,032 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213779
- Sponsor's protocol ID
- Chi-ARDS
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Observational, 8-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of China
- ClinicalTrials.gov ID
- NCT06213779
- Acronym / sponsor ID
- Chi-ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,032 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- Sample size calculation Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort of patients receiving respiratory support.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Age<18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of ARDS with new global definition
Time frame: 28-days
1 secondary outcome
ICU mortality
Time frame: 28-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Acute Respiratory Distress Syndrome, run by Southeast University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of ARDS with new global definition (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.