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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Covid-19; COVID; SARS-CoV-2
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center (UMMC)
    • Saint Paul, Minnesota, United States, 55103
      • M Health Fairview Bethesda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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: B lines: absent (< 3 lines), present (> 3 lines), fused; Consolidation: yes or noa. Bilateral: yes or no; Pleural Effusion: yes or no; Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities Cardiac POCUS Evaluation: Parasternal long axis; Parasternal short axisQualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressedEPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)Left ventricular (LV) mass approximation by septal thicknessLeft Ventricular Chamber Size by internal diameter at diastole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POCUS Score - Lungs	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: B lines: absent (< 3 lines), present (> 3 lines), fused; Consolidation: yes or noa. Bilateral: yes or no; Pleural Effusion: yes or no; Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities	up to 14 days
POCUS Score - Heart	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: Parasternal long axis; Parasternal short axisQualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressedEPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)Left ventricular (LV) mass approximation by septal thicknessLeft Ventricular Chamber Size by internal diameter at diastole Score each finding based on degree of abnormalities and number of sites with abnormalities	up to 14 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Matthew Yocum, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: GIM-2020-28740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No