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

April 29, 2020 updated by: Ospedale di Latisana

Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia: a Multicenter Study in the Italian Outbreak

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Udine
      • Latisana, Udine, Italy, 33053
        • Recruiting
        • SC Pronto Soccorso e Medicina d'Urgenza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No one

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
Sensitivity and Specificity of Lung Ultrasound in the diagnosis of COVID-19
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale di Latisana

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Anticipated)

May 23, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEUR-2020-Os-086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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