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临床试验/NCT06213779
NCT06213779已完成不适用

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

Southeast University, China4 个研究点 分布在 1 个国家目标入组 4,032 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,032
试验地点
4
主要终点
Development of ARDS with new global definition

研究概览

简要总结

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.

详细描述

  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.
  1. 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
  1. Sample size calculation Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

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.

结局指标

主要结局

Development of ARDS with new global definition

时间窗: 28-days

次要结局

  • ICU mortality(28-days)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Professor

Southeast University, China

研究点 (4)

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