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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04338568
Acronym
SCOUT
Enrollment
50
Registered
2020-04-08
Start date
2020-04-16
Completion date
2020-12-30
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia, Lung Ultrasound

Keywords

accuracy, inter-observer variability

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.

Interventions

DIAGNOSTIC_TESTLung 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.

Sponsors

Ziekenhuis Oost-Limburg
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the diagnosis of interstitial syndrome by lung ultrasoundwithin 2 weeks after first subject includedThe 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 variabilitywithin 2 weeks after first subject includedThe 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

Countries

Belgium

Contacts

Primary ContactMichiel J Thomeer, MD,PhD
michiel.thomeer@zol.be+3289327171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026