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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338568
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Prof. dr. Michiel Thomeer, Hasselt University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Ultrasound

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338568


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

Locations
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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
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Principal Investigator: Michiel Thomeer, MD,PhD Ziekenhuis Oost-Limburg
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
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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    Key Record Dates
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

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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:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections