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

Not Applicable

• Conditions: COVID-19 Pneumonia; Lung Ultrasound
• Interventions: Diagnostic Test: Lung ultrasound

• Registration Number: NCT04338568
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-08
• Study Start: 2020-04-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-17
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
2. positive COVID-19 nasopharyngeal swab within 10 days of inclusion
3. 18 years or older
4. Oxygen saturation of < 93% in ambient air
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LUS observer 2	Lung ultrasound	The subject will undergo a Lung Ultrasound by observer nr 2
LUS observer 1	Lung ultrasound	The subject will undergo a Lung Ultrasound by observer nr 1

Primary Outcome Measures

Name	Time	Method
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound	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	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

Trial Locations

Locations (1)

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Limburg, Belgium