跳至主要内容
临床试验/NCT04338568
NCT04338568Unknown不适用

Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia

Hasselt University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound

研究概览

简要总结

COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection.

This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
  • positive COVID-19 nasopharyngeal swab within 10 days of inclusion
  • 18 years or older
  • Oxygen saturation of < 93% in ambient air
  • Signed written informed consent

排除标准

  • Contra-indication for lung ultrasound
  • Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray

结局指标

主要结局

Accuracy of the diagnosis of interstitial syndrome by lung ultrasound

时间窗: within 2 weeks after first subject included

The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.

Inter-observer variability

时间窗: within 2 weeks after first subject included

The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is \> 0.6 measured by the Kappa score

次要结局

未报告次要终点

研究者

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

Prof. dr. Michiel Thomeer

Prof.Dr.Michiel Thomeer

Hasselt University

研究点 (2)

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