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

Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia

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).

Study Overview

• Status: Unknown
• Conditions: Covid-19 Pneumonia
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Piersante Sestini, MD; Phone Number: +393356247055; Email: piersante.sestini@unisi.it

Study Locations

• Italy
  • Si
    • Siena, Si, Italy, 53100
      • Recruiting
      • Azienda Ospedaliera Universitaria Senese
      • Contact: Sestini Piersante, MD; Phone Number: +390577586710; Email: piersante.sestini@unisi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments	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	1 day

Collaborators and Investigators

• Sponsor: University of Siena
• Investigators: Principal Investigator: David Bennett, MD, Azienda Ospedaliera Universitaria Senese

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): June 10, 2020
• Study Completion (Anticipated): June 10, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; pneumonia; lung ultrasound
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: USCovid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The whole anonymized dataset could be shared
• IPD Sharing Time Frame: from the month of July, for one year
• IPD Sharing Access Criteria: on request by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No