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Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia (POCUSars-CoV-2)

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: NCT04370275
Recruitment Status : Unknown
Verified April 2020 by Ospedale di Latisana.
Recruitment status was:  Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ospedale di Latisana

Study Description
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Brief Summary:

Is Lung Ultrasound really useful in diagnosing COVID19? What can be the usefulness of the Lung Ultrasound in the COVID19 epidemic? In the current state of the art, Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Lung Ultrasound in the diagnosis of COVID-19 are not yet known.

Alveolar-interstitial lung diseases such as viral pneumonia and ARDS seems to have a specific ultrasound pattern that distinguishes them from bacterial pneumonia, preferentially represented by B lines, morphological irregularity of the pleural line, and small subpleural consolidations, but they could share these patterns with other pathologies, reducing specificity.

In Italy, the Lung Ultrasound represents a consolidated method for the evaluation and management of all patients who come to the ER, and what we are sure of is its high sensitivity in identifying pathological patterns.

Our preliminary data suggest that Lung Ultrasound is highly reliable not to include but to exclude the diagnosis of COVID-19 in patients with respiratory symptoms.


Condition or disease
COVID-19 Pneumonia, Viral

Detailed Description:

One of the first scientific papers published on the COVID-19 epidemic in China showed that patients still asymptomatic or paucisymptomatic, positive for SARS-CoV-2 on the RT-PCR test, presented chest CT images referring to parenchymal infiltrate with a prevalent appearance at ground-glass compatible with initial COVID-19 pneumonia.

An ongoing study anticipates that the sensitivity of chest CT is higher than that of the RT-PCR molecular test for SARS-CoV-2 (performed on the pharyngeal swab or sputum) (50 out of 51, 98%, 95% CI: 90% -100% vs 36 out of 51, 71%, IC95%: 56% -83%) in the early diagnosis of COVID-19.

Recent work seems to shows that Lung Ultrasound is effective in the clinical evaluation and diagnosis of COVID-19 pneumonia.

In a previous study, in addition, sensitivity and specificity of the Lung Ultrasound in the early diagnosis of H1N1 flu pneumonia was 94.1% (32 out of 34) and 84.8% respectively (28 out of 33), with a positive predictive value of 86.5% (32 out of 37) and a negative predictive value of 93.3% (28 out of 30).

The concordance between the lung ultrasound findings and the lung lesions found on CT has recently been demonstrated ("lobe-specific" concordance equal to 87%; "lung-specific concordance" equal to 92.5 % for the right lung and 83.6% for the left lung).

These data suggest to better explore the diagnostic accuracy of the Lung Ultrasound in SARS-CoV-2 infection.

Study Design
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Study Type : Observational
Estimated Enrollment : 235 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia: a Multicenter Study in the Italian Outbreak
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : May 23, 2020
Estimated Study Completion Date : May 31, 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. Negative Predictive Value of Lung Ultrasound in the diagnosis of COVID-19 [ Time Frame: 30 days ]
    Lung Ultrasound accuracy in rule-out of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards


Secondary Outcome Measures :
  1. Positive Predictive Value of Lung Ultrasound in the diagnosis of COVID-19 [ Time Frame: 30 days ]
    Lung Ultrasound accuracy in rule-in of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards

  2. Sensitivity and Specificity of Lung Ultrasound in the diagnosis of COVID-19 [ Time Frame: 30 days ]

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:   No
Sampling Method:   Probability Sample
Study Population
People entering the Emergency Room during the SARS-CoV-2 epidemic
Criteria

Inclusion Criteria:

  • Fever and/or
  • Cough and/or
  • Dyspnoea

Exclusion Criteria:

  • No one
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): NCT04370275


Contacts
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Contact: Carmine C Di Gioia, MD +39 349 381 2503 crisdigioia@yahoo.it
Contact: Daniele Orso, MD +39 329 016 2763 sd7782.do@gmail.com

Locations
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Italy
SC Pronto Soccorso e Medicina d'Urgenza Recruiting
Latisana, Udine, Italy, 33053
Contact: Roberto Copetti, MD, Director    +39 340 245 4399    robcopet@gmail.com   
Sponsors and Collaborators
Ospedale di Latisana
Investigators
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Principal Investigator: Roberto Copetti, MD, Director Ospedale di Latisana
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ospedale di Latisana
ClinicalTrials.gov Identifier: NCT04370275    
Other Study ID Numbers: CEUR-2020-Os-086
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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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 Ospedale di Latisana:
Covid-19
Lung Ultrasound
POCUS
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases