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

NCT04339998 | Completed

• 1 other identifier: GIM-2020-28740
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

Specific Aims:

1. 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. 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.

Conditions

Coronavirus Infection; COVID; Covid-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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: 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

  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: 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

  up to 14 days

Study Arms (1)

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)

Interventions

Point-of-Care Ultrasonography (POCUS) DIAGNOSTIC_TEST

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

Patients with Suspected or Confirmed COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- ultrasound contraindication such as overlying skin wound

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Minnesota Medical Center (UMMC)

Minneapolis, Minnesota, 55455, United States

Location

M Health Fairview Bethesda Hospital

Saint Paul, Minnesota, 55103, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthew Yocum, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: April 15, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

US (2)