Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19 Pneumonia, Lung Ultrasound

Intervention / Treatment
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* Diagnostic Test: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Contra-indication for lung ultrasound Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with the diagnosis of COVID-19 pneumonia will undergo a lung ultrasound, by two observers each. The findings will be compared with findings on chest x-ray and/or CT thorax. Accuracy and inter-observer variability will be calculated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LUS observer 1<br>The subject will undergo a Lung Ultrasound by observer nr 1 | Diagnostic Test: Lung ultrasound<br>* The lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position.<br>|
| Active Comparator: LUS observer 2<br>The subject will undergo a Lung Ultrasound by observer nr 2 | Diagnostic Test: Lung ultrasound<br>* The lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the diagnosis of interstitial syndrome by lung ultrasound | 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. | within 2 weeks after first subject included | 
| Inter-observer variability | 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 | within 2 weeks after first subject included | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accuracy, inter-observer variability