Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia

NCT04370275 | Unknown

• 1 other identifier: CEUR-2020-Os-086
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Pneumonia, Viral

Keywords

Covid-19; Lung Ultrasound; POCUS

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value of Lung Ultrasound in the diagnosis of COVID-19

  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

  30 days

Secondary Outcomes (2)

• Positive Predictive Value of Lung Ultrasound in the diagnosis of COVID-19

  30 days

• Sensitivity and Specificity of Lung Ultrasound in the diagnosis of COVID-19

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People entering the Emergency Room during the SARS-CoV-2 epidemic

You may qualify if:

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

You may not qualify if:

• No one

Sponsors & Collaborators

• Ospedale di Latisana: lead

Study Sites (1)

SC Pronto Soccorso e Medicina d'Urgenza

Latisana, Udine, 33053, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 32105637 BACKGROUND

• 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.

  PMID: 31939782 BACKGROUND

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 22340202 BACKGROUND

• 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.

  PMID: 18442425 BACKGROUND

• 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.

  PMID: 15735264 BACKGROUND

• 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.

  PMID: 22862998 BACKGROUND

• 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.

  PMID: 34937709 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberto Copetti, MD, Director

  Ospedale di Latisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmine C Di Gioia, MD

CONTACT

+39 349 381 2503; crisdigioia@yahoo.it

Daniele Orso, MD

CONTACT

+39 329 016 2763; sd7782.do@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: April 30, 2020
• Study Start: April 23, 2020
• Primary Completion: May 23, 2020
• Study Completion: May 31, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

IT (1)