Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia
NCT ID: NCT04370275
Last Updated: 2020-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
235 participants
OBSERVATIONAL
2020-04-23
2020-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Cough and/or
* Dyspnoea
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ospedale di Latisana
OTHER
Responsible Party
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Principal Investigators
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Roberto Copetti, MD, Director
Role: PRINCIPAL_INVESTIGATOR
Ospedale di Latisana
Locations
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SC Pronto Soccorso e Medicina d'Urgenza
Latisana, Udine, Italy
Countries
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Central Contacts
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Facility Contacts
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Roberto Copetti, MD, Director
Role: primary
References
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Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
Tierney DM, Huelster JS, Overgaard JD, Plunkett MB, Boland LL, St Hill CA, Agboto VK, Smith CS, Mikel BF, Weise BE, Madigan KE, Doshi AP, Melamed RR. Comparative Performance of Pulmonary Ultrasound, Chest Radiograph, and CT Among Patients With Acute Respiratory Failure. Crit Care Med. 2020 Feb;48(2):151-157. doi: 10.1097/CCM.0000000000004124.
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Testa A, Soldati G, Copetti R, Giannuzzi R, Portale G, Gentiloni-Silveri N. Early recognition of the 2009 pandemic influenza A (H1N1) pneumonia by chest ultrasound. Crit Care. 2012 Feb 17;16(1):R30. doi: 10.1186/cc11201.
Copetti R, Soldati G, Copetti P. Chest sonography: a useful tool to differentiate acute cardiogenic pulmonary edema from acute respiratory distress syndrome. Cardiovasc Ultrasound. 2008 Apr 29;6:16. doi: 10.1186/1476-7120-6-16.
Carley S, Dosman S, Jones SR, Harrison M. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J. 2005 Mar;22(3):180-1. doi: 10.1136/emj.2003.011148.
Tsung JW, Kessler DO, Shah VP. Prospective application of clinician-performed lung ultrasonography during the 2009 H1N1 influenza A pandemic: distinguishing viral from bacterial pneumonia. Crit Ultrasound J. 2012 Jul 10;4(1):16. doi: 10.1186/2036-7902-4-16.
Di Gioia CC, Artusi N, Xotta G, Bonsano M, Sisto UG, Tecchiolli M, Orso D, Cominotto F, Amore G, Meduri S, Copetti R. Lung ultrasound in ruling out COVID-19 pneumonia in the ED: a multicentre prospective sensitivity study. Emerg Med J. 2022 Mar;39(3):199-205. doi: 10.1136/emermed-2020-210973. Epub 2021 Dec 22.
Other Identifiers
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CEUR-2020-Os-086
Identifier Type: -
Identifier Source: org_study_id