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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379544
Recruitment Status : Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
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

  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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379544


Locations
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United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Felipe Teran, MD University of Pennsylvania
Additional Information:
Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04379544    
Other Study ID Numbers: 843008
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
COVID-19
Ultrasound
Point-of-care
Lung Ultrasound
Focused Echocardiography
Emergency Department
ICU
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders