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

NCT ID: NCT04339998

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2020-10-01

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Point-of-Care Ultrasonography (POCUS)

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Yocum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center (UMMC)

Minneapolis, Minnesota, United States

M Health Fairview Bethesda Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

GIM-2020-28740

Identifier Type: -

Identifier Source: org_study_id