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

NCT04338568 | Unknown

• 1 other identifier: CTU2020032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia; Lung Ultrasound

Keywords

accuracy; inter-observer variability

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

LUS observer 1

ACTIVE COMPARATOR

The subject will undergo a Lung Ultrasound by observer nr 1

Diagnostic Test: Lung ultrasound

LUS observer 2

ACTIVE COMPARATOR

The subject will undergo a Lung Ultrasound by observer nr 2

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

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.

LUS observer 1; LUS observer 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Oxygen saturation of \< 93% in ambient air
• Signed written informed consent

You may not qualify if:

• Contra-indication for lung ultrasound
• Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 24998675 BACKGROUND

• 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.

  PMID: 31346914 RESULT

• 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.

  PMID: 32215691 RESULT

Study Officials

• Michiel Thomeer, MD,PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel J Thomeer, MD,PhD

CONTACT

+3289327171; michiel.thomeer@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Michiel Thomeer

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 8, 2020
• Study Start: April 16, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)