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

• ClinicalTrials.gov Identifier: NCT04338568
• Recruitment Status: Unknown
• First Posted: April 8, 2020
• Last Update Posted: August 17, 2020
• Sponsor: Hasselt University
• Collaborator: Ziekenhuis Oost-Limburg
• Information provided by (Responsible Party): Prof. dr. Michiel Thomeer, Hasselt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19 Pneumonia; Lung Ultrasound	Diagnostic Test: Lung ultrasound	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Diagnostic
• Official Title: Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia
• Actual Study Start Date: April 16, 2020
• Estimated Primary Completion Date: November 30, 2020
• Estimated Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: LUS observer 1; The subject will undergo a Lung Ultrasound by observer nr 1	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.
Active Comparator: LUS observer 2; The subject will undergo a Lung Ultrasound by observer nr 2	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.

Outcome Measures

Primary Outcome Measures :

1. Accuracy of the diagnosis of interstitial syndrome by lung ultrasound [ Time Frame: 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.
2. Inter-observer variability [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Michiel J Thomeer, MD,PhD; +3289327171; michiel.thomeer@zol.be

Locations

Belgium

Ziekenhuis Oost Limburg; Recruiting

Genk, Limburg, Belgium, 3600

Contact: Michiel J Thomeer, MD, PhD +3289327171 michiel.thomeer@zol.be

Contact: Inge Thijs, PhD +3289212007 Inge.Thijs@zol.be

Sub-Investigator: Marc Daenen, MD

Sub-Investigator: David Ruttens, MD, PhD

Principal Investigator: Michiel Thomeer, MD, PhD

Sponsors and Collaborators

Hasselt University

Ziekenhuis Oost-Limburg

Investigators

• Principal Investigator: Michiel Thomeer, MD,PhD; Ziekenhuis Oost-Limburg

More Information

Study Data/Documents: Clinical Study Report 

Publications of Results:

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 scores - a post hoc analysis of an observational study in invasively ventilated ICU patients. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):44. doi: 10.1186/s40635-019-0241-6.

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 2020 Mar 25.

Other Publications:

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. No abstract available.

• Responsible Party: Prof. dr. Michiel Thomeer, Prof.Dr.Michiel Thomeer, Hasselt University
• ClinicalTrials.gov Identifier: NCT04338568
• Other Study ID Numbers: CTU2020032
• First Posted: April 8, 2020
• Last Update Posted: August 17, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: no plan

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. dr. Michiel Thomeer, Hasselt University:

accuracy; inter-observer variability

Additional relevant MeSH terms:

COVID-19; Pneumonia; Respiratory Tract Infections; Infections; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases