跳至主要内容
临床试验/NCT06069466
NCT06069466Enrolling By Invitation不适用

Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome in China RICUs-CHARDS II Study

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
1
主要终点
the prognosis of ARDS patients

研究概览

简要总结

This project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ARDS patients in RICU. By collecting 1,000 patients, a clinical database related to ARDS in China was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ARDS patients and further clinical intervention research. At the same time, ARDS biobank was established in China-Japan Hospital and Xiangya Hospital to realize the integration of clinical data and sample resources, and the prediction model of ARDS survival and complications of tuberculosis clinical data and biological samples was established by using big data and AI technology.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • New or worsening respiratory symptoms less than 7 days after the acute blow.
  • CT/X-ray: Double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule.
  • Respiratory failure that cannot be explained by heart failure or fluid overload
  • After 15min assisted ventilation (PEEP or CPAP ≥ 5cmH2O) or HFNC with flow≥30L/min, PaO2/FiO2≤300mmHg
  • Classification of ARDS: mild (200mmHg < PaO2/FIO2 ≤ 300mmHg), moderate (100mmHg < PaO2/FIO2 ≤ 200mmHg), and severe (PaO2/FIO2 ≤ 100mmHg) and 4 ancillary variables for severe ARDS

排除标准

  • younger than 18 years old
  • Patients or family members refused to participate in the study

结局指标

主要结局

the prognosis of ARDS patients

时间窗: from 28d to 1 year

ICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients

次要结局

  • Incidence of ARDS in ICUs(2 years)
  • Length of hospital stay in ARDS patients(during hospitalization)
  • VFDs within 28 days(28 days)
  • Long-term quality of life and long-term lung function(1 year)
  • Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines(during hospitalization)
  • Survival risk factors in hospitalized ARDS patients(during hospitalization)
  • Risk factors for ARDS complications(during hospitalization)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Xu

associate chief physician

China-Japan Friendship Hospital

研究点 (1)

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