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Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)

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ClinicalTrials.gov Identifier: NCT04339998
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:

Specific Aims:

  1. The investigators will prospectively evaluate and analyze changes in the appearance of the lungs and heart through serial acquisition of focused point-of-care ultrasound images in a cohort of patients with or under investigation for COVID-19.
  2. The investigators will correlate changes noted in ultrasound with clinical course and diagnostic evaluation to ascertain whether changes on ultrasound could improve care through earlier diagnosis or identification of patients at high risk of disease progression.

Condition or disease Intervention/treatment
Coronavirus Infection COVID Covid-19 SARS-CoV-2 Diagnostic Test: Point-of-Care Ultrasonography (POCUS)

Detailed Description:

The investigators will perform a descriptive study aimed at identifying the cardiopulmonary ultrasound features in patients with or under investigation for COVID-19.

The study will take place at two sites: University of Minnesota Medical Center (UMMC) and Bethesda Hospital. At UMMC, a tertiary care center, clinicians will recruit and evaluate patients with or under investigation for COVID-19. At Bethesda clinicians will recruit and evaluate patients with a confirmed diagnosis of COVID-19 as demonstrated by a positive PT-PCR.

POCUS exams will be performed in a cohort of 200-500 patients with or under investigation for COVID-19. Serial ultrasound examinations will be performed every 48-72 hours until discharge, death, or study completion. Participants will undergo POCUS at enrollment by their treating physicians. Inquiry into study enrollment will be performed over the phone rather than in person, given the current scarcity of PPE and the added use that would occur with in-person enrollment.

Study Design
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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
Actual Study Start Date : April 15, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Suspected or Confirmed COVID-19
Patients 18 years of age and older under investigation for COVID-19 and those patients that are positive for COVID-19 at University of Minnesota Medical Center and Bethesda Hospital. Informed consent will be obtained from the patient or decision maker prior to study inclusion
 Diagnostic Test: Point-of-Care Ultrasonography (POCUS)

The POCUS exam of the heart will capture 2 standard views commonly used to assess general cardiac function at the point of care. The details of POCUS views and exam findings of interest are outline below:

Pulmonary POCUS Evaluation:

  1. B lines: absent (< 3 lines), present (> 3 lines), fused

  2. Consolidation: yes or no

    a. Bilateral: yes or no

  3. Pleural Effusion: yes or no
  4. Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities

Cardiac POCUS Evaluation:

  1. Parasternal long axis

  2. Parasternal short axis

    1. Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed
    2. EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)
    3. Left ventricular (LV) mass approximation by septal thickness
    4. Left Ventricular Chamber Size by internal diameter at diastole


Outcome Measures
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Primary Outcome Measures :
  1. POCUS Score - Lungs [ Time Frame: up to 14 days ]

    POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the lungs. Higher scores indicate greater malady.

    Pulmonary POCUS Evaluation:

    1. B lines: absent (< 3 lines), present (> 3 lines), fused

    2. Consolidation: yes or no

      a. Bilateral: yes or no

    3. Pleural Effusion: yes or no
    4. Other pleural abnormalities: yes or no

    Score each finding based on degree of abnormalities and number of sites with abnormalities


  2. POCUS Score - Heart [ Time Frame: up to 14 days ]

    POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the heart. Higher scores indicate greater malady.

    Cardiac POCUS Evaluation:

    1. Parasternal long axis

    2. Parasternal short axis

      1. Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed
      2. EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)
      3. Left ventricular (LV) mass approximation by septal thickness
      4. Left Ventricular Chamber Size by internal diameter at diastole

    Score each finding based on degree of abnormalities and number of sites with abnormalities



Eligibility Criteria
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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:   Probability Sample
Study Population
Patients 18 years of age and older under investigation for COVID-19 and those patients that are positive for COVID-19 at UMMC and Bethesda. Informed consent will be obtained from the patient or decision maker prior to study inclusion.
Criteria

Inclusion Criteria:

  • patients under investigation for COVID-19
  • patients that are positive for COVID-19 at UMMC and Bethesda

Exclusion Criteria:

- ultrasound contraindication such as overlying skin wound

Contacts and Locations
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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): NCT04339998


Locations
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United States, Minnesota
University of Minnesota Medical Center (UMMC)
Minneapolis, Minnesota, United States, 55455
M Health Fairview Bethesda Hospital
Saint Paul, Minnesota, United States, 55103
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Matthew Yocum, MD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04339998    
Other Study ID Numbers: GIM-2020-28740
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases