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Reliability of a Pocket Sized Ultrasound Scanner in the Evaluation Covid-19 Pneumonia (USCovid)

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ClinicalTrials.gov Identifier: NCT04433000
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Piersante Sestini, University of Siena

Brief Summary:

Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients. The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia, in comparison with a high end ultrasound scanner.

Statisical analysis will be performed with Stata for Windows V 16 (Stata corp, Texas College, TX). Power size estimation using Medcalc 19.3.1, (MedCalc Software Ltd, Ostenda, B) showed that hat 34 patients would be required for the comparison of the two methods using the Bland-Altman method assuming a mean difference in total score of 1±1, a false positive rate (α) of 0.05 and a false negative rate of 0.1 (β=0.9).


Condition or disease Intervention/treatment
Covid-19 Pneumonia Diagnostic Test: Butterfly

Detailed Description:

Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China in December 2019 and quickly spread all over the globe. The clinical features are fever, dyspnoea, dry cough, fatigue and diarrhoea (1). Pharyngodynia, nasal congestion, rhinorrhoea and anosmia have also been reported . Interstitial pneumonia is very common and a high percentage of patients (9-11%) develop severe acute respiratory distress syndrome (ARDS) and require intensive care. Current therapeutic strategy involves agents counteracting viral invasion and replication, and inhibitors of cytokine-sustained inflammatory reactions. No specific antiviral therapy has yet been identified.

Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients, due to the typical sonographic characteristics of affected lungs. It provides indications for clinical decisions and the management of associated respiratory failure and lung injury.

The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia.

We will perform 34 LUS (lung ultrasound scan) evaluations on patients admitted to the COVID Unit of Siena University Hospital with symptoms compatible with COVID-19, a positive SARS-CoV-2 nasal-pharyngeal swab and radiological evidence of interstitial pneumonia.

The patients will be divided into three severity categories based on respiratory impairment: Mild PaO2/FiO2 > 300 in room air or oxygen flow; Moderate PaO2/FiO2 between 150 and 300 in room air or oxygen-therapy, CPAP, NIV or HFNC; Severe PaO2/FiO2 < 150 on oxygen-therapy, CPAP, NIV, HFNC or mechanical ventilation.

The lung ultrasound scans will be performed on the same day with a standard ultrasound scanner (GE Healthcare, Venue GO) and a pocket-sized ultrasound scanner (Butterfly Network Inc., Butterfly iQ) for clinical purposes; lung preset will be used with both scanners. Up to six regions of the chest will be identified: anterosuperior (A); anteroinferior (B); lateralsuperior (C); lateralinferior (D); posterosuperior (E); posteroinferior (F). One of four different aeration patterns will be recorded according to a specific scoring system: A = 0 points (normal aeration, presence of lung sliding with A lines or less than two isolated B lines), B1 = 1 point (moderate loss of lung aeration, multiple well-defined B lines), B2 = 2 points (severe loss of lung aeration, multiple coalescent B lines), C = 3 points (lung consolidation and tissue-like pattern). Pleural effusion and pneumothorax were also recorded. A score of 0 was normal and 36 was the worst. Due to clinical conditions, the upper posterior region (E) could not be explored in some patients, so the mean of the regions explored will be calculated for the purposes of statistical analysis (total sum (0 to 36) divided by number of regions explored (5 or 6 on each side).

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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Ultrasound


Intervention Details:
  • Diagnostic Test: Butterfly
    Standardized lung ultrasound scan with two different instruments
    Other Name: GE Healthcare Venue GO


Primary Outcome Measures :
  1. Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments [ Time Frame: 1 day ]
    The more widely accepted measure of agreement beteen two instruments. Bland JM, Altman DG (1986) Statistical method for assessing agreement between two methods of clinical measurement. The Lancet i:307-310



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
Criteria

Inclusion Criteria:

  • Admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography

Exclusion Criteria:

  • Unable/unwilling to cooperate

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): NCT04433000


Contacts
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Contact: Piersante Sestini, MD +393356247055 piersante.sestini@unisi.it

Locations
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Italy
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Si, Italy, 53100
Contact: Sestini Piersante, MD    +390577586710    piersante.sestini@unisi.it   
Sponsors and Collaborators
University of Siena
Investigators
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Principal Investigator: David Bennett, MD Azienda Ospedaliera Universitaria Senese
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Responsible Party: Piersante Sestini, Associate professor of respiratory diseases, University of Siena
ClinicalTrials.gov Identifier: NCT04433000    
Other Study ID Numbers: USCovid
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The whole anonymized dataset could be shared
Supporting Materials: Study Protocol
Time Frame: from the month of July, for one year
Access Criteria: on request by email

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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 Piersante Sestini, University of Siena:
Covid-19
pneumonia
lung ultrasound
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections