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临床试验/NCT04668196
NCT04668196已完成不适用

Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)

Hospital Universitari Vall d'Hebron Research Institute10 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
367
试验地点
10
主要终点
Treatment failure

研究概览

简要总结

COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.

详细描述

Multicenter, retrospective, longitudinal study in consecutive adult COVID-19 patients with acute respiratory failure, requiring noninvasive respiratory support (NIRS) outside the intensive care unit (ICU) in 10 hospitals in Catalonia (Spain). Demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section).

During the hospitalization, patients were treated according to the standard procedures of the participating centers. This study is observational and no randomization have been performed.

Patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from NIRS initiation.

研究设计

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

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

  • COVID-19 pneumonia confirmed with polymerase chain reaction (PCR).
  • Acute respiratory failure.
  • Treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP or noninvasive ventilation), initiated outside the intensive care unit.
  • Age > 18 years

排除标准

  • Acute respiratory failure not related to COVID-19
  • Hypercapnic acute respiratory failure
  • Early intolerance to treatment
  • Nosocomial infection
  • Pregnant woman

结局指标

主要结局

Treatment failure

时间窗: 28 days within noninvasive respiratory support initiation

Death or endotracheal intubation

次要结局

  • Duration of hospital stay(Until 28 days from noninvasive respiratory support initiation)
  • 28-day mortality(28 days within noninvasive respiratory support initiation)
  • Hospital mortality(Until 28 days from noninvasive respiratory support initiation)
  • Endotracheal intubation(28 days within noninvasive respiratory support initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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