CLUSCO: Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19

Sponsor

University of Pennsylvania (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04379544

Collaborator

(none)

125

Enrollment

Location

19.3

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Respiratory Failure	Other: Observation only

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

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

Specific aims

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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Positive Patients Receiving CPUS Adult patients (18 years) presenting to the ED or ICU with highly suspected diagnosis or confirmed diagnosis of COVID-19 in whom the clinician deems a CPUS (cardiopulmonary ultrasound) is indicated.	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.

Arm

Intervention/Treatment

COVID-19 Positive Patients Receiving CPUS

Adult patients (18 years) presenting to the ED or ICU with highly suspected diagnosis or confirmed diagnosis of COVID-19 in whom the clinician deems a CPUS (cardiopulmonary ultrasound) is indicated.

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.

Outcome Measures

Primary Outcome Measures

Patient requires invasive mechanical ventilation and suffers from acute respiratory failure. [1 Year]
Number of patients requiring invasive mechanical ventilation and suffers from acute respiratory failure.
Patient is discharged [1 Year]
Number of patients that do not require hospitalization and is able to safely recover from COVID-19 at home.
Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay. [1 Year]
Number of patients that must be hospitalized to recover from COVID-19, but does not require invasive mechanical ventilation and may or may not suffer from some degree of acute respiratory failure.

Secondary Outcome Measures

Lung ultrasound findings [1 year]
Any lung ultrasound findings including, but not limited to b-lines, a-lines, consolidations, pleural effusions and regularities. All of these findings are consolidated to a single score which will be the measure of the severity of lung ultrasound findings.
Cardiac ultrasound findings [1 year]
Any cardiac ultrasound findings including, but not limited to IVC status, pericardial effusions, LV EF (%), RV function. All of these findings are consolidated to a single score which will be the measure of the severity of cardiac ultrasound findings.