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

COVID-19 Pneumonia Clinical Trial

— SCOUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338568
• Other study ID #: CTU2020032
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Hasselt University
• Contact: Michiel J Thomeer, MD,PhD
• Phone: +3289327171
• Email: michiel.thomeer[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Lung Ultrasound
• Pneumonia

Intervention

Diagnostic Test:
• Lung ultrasound
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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Li K, Fang Y, Li W, Pan C, Qin P, Zhong Y, Liu X, Huang M, Liao Y, Li S. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol. 2020 Aug;30(8):4407-4416. doi: 10.1007/s00330-020-06817-6. Epub 202 — View Citation

Pisani L, Vercesi V, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MAM, Henwood PC, Walden A, Smit MR, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. The diagnostic accuracy for ARDS of global versus regional lung ultrasound — View Citation

Ramirez P, Torres A. Should ultrasound be included in the initial assessment of respiratory patients? Lancet Respir Med. 2014 Aug;2(8):599-600. doi: 10.1016/S2213-2600(14)70142-0. Epub 2014 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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