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The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327674
Recruitment Status : Unknown
Verified March 2020 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings.

Focused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital.

This study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.


Condition or disease
COVID-19

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19
Actual Study Start Date : March 14, 2020
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. FLUS findings and respiratory failure [ Time Frame: Up to 3 months. ]
    Analysis of FLUS related to risk of development of respiratory failure.


Secondary Outcome Measures :
  1. FLUS findings and chest x-ray. [ Time Frame: Up to 3 months. ]
    Analysis of FLUS related to risk of result of chest x-ray

  2. FLUS findings and admission to intensive care. [ Time Frame: Up to 3 months. ]
    Analysis of FLUS related to risk of intensive care admission

  3. FLUS findings and SAR-CoV-2 PCR-test result. [ Time Frame: Up to 3 months. ]
    Analysis of FLUS related to result from SAR-CoV-2 PCR-test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients who have symptoms on COVID-19 and is seen at a hospital.
Criteria

Inclusion Criteria:

  • Clinical suspicion of COVID-19 requiring contact to a hospital.

Exclusion Criteria:

  • Age less than 18 years
  • Previous enrollment in this study.
Contacts and Locations
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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): NCT04327674


Contacts
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Contact: Søren H Skaarup 28911869 soeska@rm.dk

Locations
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Denmark
Lungemedicinsk Forskningsafdeling. Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Søren Helbo SH Skaarup, MD    +45 28911869    soeska@rm.dk   
Regionshospitalet Horsens. Recruiting
Horsens, Denmark
Contact: Jesper Weile         
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Søren H Skaarup Aarhus Universitets Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04327674    
Other Study ID Numbers: COVID-FLUS
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases