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

NCT ID: NCT06213779

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Failure Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Ling Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan friendship hospital

Beijin, , China

Site Status RECRUITING

Zhongda Hospital, Southeast university

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Liu, PhD

Role: CONTACT

+86-02583262550

Facility Contacts

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Jingen Xia, MD

Role: primary

Ling Liu, PhD

Role: primary

Other Identifiers

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Chi-ARDS

Identifier Type: -

Identifier Source: org_study_id

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