Clinical trial NCT04379544: Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
Official title: Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Respiratory Failure
Keywords: COVID-19
Ultrasound
Point-of-care
Lung Ultrasound
Focused Echocardiography
Emergency Department
ICU
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) patients presenting to the ED and ICU with suspected diagnosis or confirmed diagnosis of COVID-19 in whom the clinician deems a CLUS indicated.

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

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

Primary outcomes:
measure: Patient requires invasive mechanical ventilation and suffers from acute respiratory failure.
timeFrame: 1 Year
measure: Patient is discharged
timeFrame: 1 Year
measure: Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay.
timeFrame: 1 Year
Secondary outcomes:
measure: Lung ultrasound findings
timeFrame: 1 year
measure: Cardiac ultrasound findings
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Felipe Teran, MD
role: PRINCIPAL_INVESTIGATOR
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