跳至主要内容
临床试验/NCT04871685
NCT04871685Unknown不适用

ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2020年10月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
950
试验地点
1
主要终点
validation of lung ultrasound score

研究概览

简要总结

Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas.

The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women;
  • confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
  • any symptom at hospitalization
  • any therapy
  • any pre-existing comorbidity

排除标准

  • pregnant women
  • healthy subjects with other respiratory diseases different from COVID-19

结局指标

主要结局

validation of lung ultrasound score

时间窗: 6 months

validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19

次要结局

  • Association of LUS score with clinical outcome(6 months)
  • Association of LUS score with duration of hospitalization (days)(6 months)
  • Association of LUS score with respiratory support required(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Rinaldi

Researcher

University of Campania "Luigi Vanvitelli"

研究点 (1)

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