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

• ClinicalTrials.gov Identifier: NCT04370275
• Recruitment Status: Unknown
• First Posted: April 30, 2020
• Last Update Posted: April 30, 2020
• Sponsor: Ospedale di Latisana
• Information provided by (Responsible Party): Ospedale di Latisana

Tracking Information

• First Submitted Date: April 29, 2020
• First Posted Date: April 30, 2020
• Last Update Posted Date: April 30, 2020
• Actual Study Start Date: April 23, 2020
• Estimated Primary Completion Date: May 23, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2020)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 29, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia
• Official Title: Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia: a Multicenter Study in the Italian Outbreak

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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: People entering the Emergency Room during the SARS-CoV-2 epidemic

Condition

• COVID-19
• Pneumonia, Viral

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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. Erratum In: Emerg Med J. 2005 May;22(5):392.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 29, 2020): 235
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2020
• Estimated Primary Completion Date: May 23, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• No one

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04370275
• Other Study ID Numbers: CEUR-2020-Os-086
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ospedale di Latisana
• Original Responsible Party: Same as current
• Current Study Sponsor: Ospedale di Latisana
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Roberto Copetti, MD, Director; Ospedale di Latisana

• PRS Account: Ospedale di Latisana
• Verification Date: April 2020