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

September 18, 2023 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • COVID-19 positive or suspected positive
  • Received a cardiopulmonary ultrasound scan

Exclusion Criteria:

  • Did not receive a scan
  • Not COVID-19 positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient requires invasive mechanical ventilation and suffers from acute respiratory failure.
Time Frame: 1 Year
Number of patients requiring invasive mechanical ventilation and suffers from acute respiratory failure.
1 Year
Patient is discharged
Time Frame: 1 Year
Number of patients that do not require hospitalization and is able to safely recover from COVID-19 at home.
1 Year
Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay.
Time Frame: 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.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound findings
Time Frame: 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.
1 year
Cardiac ultrasound findings
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Felipe Teran, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 843008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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