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临床试验/NCT04327674
NCT04327674已完成不适用

The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

University of Aarhus2 个研究点 分布在 1 个国家目标入组 417 人开始时间: 2020年3月14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
417
试验地点
2
主要终点
Mechanical Ventilation

研究概览

简要总结

COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings.

Focused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital.

This study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.

详细描述

COVID-19 is defined as an infectious disease caused by SAR-CoV-2 virus. It results in pneumonia and sometimes respiratory failure. SARS-CoV-2 pandemic has led to massive strain on health care facilities. A large proportion of the population is at risk of COVID-19 and some estimates suggest that up to 15% will need hospitalization. Such number of patients strains the health care system to its maximum as capacity has limitations even in highly developed countries.

Early reports estimate that more than 80% of patients admitted to hospital with COVID-19 have abnormal findings on chest radiographs1. Thus, imaging seems to be an important part of the diagnostic work-up. In most hospitals however, access to CT-scanning of the thorax of all patients with COVID-19 or with suspicion of CODIV-19 is unrealistic due to restricted capacity. Chest radiographs are faster and easier to do, but may require transportation of the patient to the department of radiology which carries a risk of virus spreading in the hospital. On-site chest radiograph is often of such low quality that diagnosis or follow-up will be difficult.

Focused ultrasound examination of the lungs, FLUS, is a diagnostic tool that can show changes in the lung parenchyma due to pneumonia. FLUS is a bed-side examination performed by the physician which results in reduced risk of in-hospital virus contamination. Furthermore, results from FLUS are immediately available to the physician. This allows rapid decision-making which is essential in cases of high patient burdens as seen in the COVID-19 pandemic.

Furthermore, SARS-CoV-2 positive patients with pneumonia may be at higher risk of respiratory failure than those without pneumonia. Identifying patients at high risk can qualify decisions about monitoring level and organization of intensive care resources. Conversely, patient with COVID-19 symptoms but without pneumonic FLUS finding could likely be managed as out-patients. Such a risk-stratification may optimize the allocation of limited healthcare resources and reserve in-hospital capacity to those patients who needs it.

Hypothesis:

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

  • Clinical suspicion of COVID-19 requiring contact to a hospital.

排除标准

  • Age less than 18 years
  • Previous enrollment in this study.

结局指标

主要结局

Mechanical Ventilation

时间窗: During admission, an average of 1 day

Number of patients on mechanical ventilation.

次要结局

  • FLUS Findings and Admission to Intensive Care.(During admission, an average of 1 day)
  • SAR-CoV-2 PCR-test Result.(During admission, an average of 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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