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

Hasselt University

Status: Unknown

Conditions: Lung Ultrasound; COVID-19 Pneumonia

Treatments: Diagnostic Test: Lung ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04338568

CTU2020032

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LUS observer 1

Active Comparator group

Description:

The subject will undergo a Lung Ultrasound by observer nr 1

Treatment:

Diagnostic Test: Lung ultrasound

LUS observer 2

Active Comparator group

Description:

The subject will undergo a Lung Ultrasound by observer nr 2

Treatment:

Diagnostic Test: Lung ultrasound