Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
Condition: Coronavirus; Respiratory Failure
MeSH terms: COVID-19; Respiratory Insufficiency
Study type: Observational [Patient Registry]

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
    

Intervention name(s): Observation only
Intervention type(s): Other
Intervention description(s): 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.
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.
      
Keywords: COVID-19; Ultrasound; Point-of-care; Lung Ultrasound; Focused Echocardiography; Emergency Department; ICU