Official Title
Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
Brief Summary

This is a protocol-driven observational study of lung ultrasound and focused echocardiography images obtained in the Emergency Department (ED) and Intensive Care Unit (ICU) settings as a part of existing standard of care. The objectives of this study are as follows: 1. To characterize various clinical and cardiopulmonary ultrasound findings and describe their relationship with the clinical course of patients with COVID-19 in the ED and ICU. 2. To describe, develop, and validate a prediction tool that can accurately predict the need for invasive mechanical ventilation (IMV) and acute respiratory failure in COVID-19 patients using clinical, laboratory, and ultrasound data.

Detailed Description

Background and scientific rationale:

During the COVID-19 pandemic, health care systems around the world are overwhelmed.

Surge of patients requiring hospital admission have led to shortages of ICU beds and
mechanical ventilators. As an emerging clinical entity, little is known about the precise
pathophysiologic mechanisms of COVID-19. Recent observational data and clinical experience
has suggested that there could be different phenotypes of patients with COVID-19 which could
explain the wide range of clinical presentations, response to therapies and outcomes.

Point of care cardiac and lung ultrasound (CLUS) has been proposed as a tool with potential
to assist diagnostic evaluation and management of COVID-19 patients in the emergency
department (ED) and intensive care unit (ICU) settings. Point of care CLUS is routinely used
as part of the clinical evaluation of patients with dyspnea, hypoxemia, chest pain and shock
in the ED and ICU. Patients with COVID-19 commonly present to the ED with these symptoms and
therefore CLUS is being commonly used in patients with suspected or confirmed diagnosis of
COVID-19.

Small observational studies have described several lung ultrasound (LUS) findings in patients
with COVID-19. These findings include; pleural irregularity ("thickening"), subpleural
consolidations, air bronchogram, isolated B-lines, fused B-lines and pleural effusions. Other
observational studies have described the presence of acute myocardial abnormalities in
patients with COVID-19 seen in echocardiography, including left and right ventricular
systolic dysfunction.

Multiple studies have described and validated the finding of B-lines in LUS as a non-invasive
marker of extravascular lung water. B-lines in LUS correlate with pulmonary capillary wedge
pressures, NT-proBNP and E/e' and has been validated as a reliable prognostic factor in
patients with decompensated heart failure. B-lines are also found in other pulmonary
processes including viral pneumonia, ARDS, pulmonary contusions and post radiation changes.
Observational studies involving COVID-19 patients have shown the presence of isolated and
fused or continuous B-lines in the pneumonia associated with this infection. We hypothesize
that the presence of B-lines in LUS may be marker of severity, and that alone or in concert
with other clinical or laboratory variables, could help predict the clinical course and
prognosis of COVID-19 patients.

Knowledge gaps

1. Does point of care cardiopulmonary ultrasound findings alone, or combined with other
clinical and/or laboratory variables, predict clinical outcomes of patients with
COVID-19?

2. Can different lung ultrasound finding patterns correlate with clinical severity or
outcomes?

Specific aims

1. To characterize various clinical and CLUS findings and describe their relationship with
clinical course of patients with COVID-19 in ED and ICU.

2. Using clinical, laboratory and ultrasound data to describe, develop and validate a
prediction tool that can accurately predict (1) need of invasive mechanical ventilation
(IVM) and (2) acute respiratory failure

Completed
Coronavirus
Respiratory Failure

Other: Observation only

There is no intervention. This study is purely observational. This study simply follows COVID-19 patients who get CPUS based on their clinician deeming it necessary.

Eligibility Criteria

Inclusion Criteria:

- COVID-19 positive or suspected positive

- Received a cardiopulmonary ultrasound scan

Exclusion Criteria:

- Did not receive a scan

- Not COVID-19 positive

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States

Felipe Teran, MD, Principal Investigator
University of Pennsylvania

University of Pennsylvania
NCT Number
Keywords
Covid-19
Ultrasound
Point-of-care
Lung ultrasound
Focused Echocardiography
emergency department
ICU
MeSH Terms
COVID-19
Respiratory Insufficiency