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.

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Key information

Conditions

Coronavirus Infection COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center (UMMC), Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

B lines: absent (< 3 lines), present (> 3 lines), fused
Consolidation: yes or no

a. 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 axis

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

Primary outcomes

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:
- B lines: absent (< 3 lines), present (> 3 lines), fused
- Consolidation: yes or no
a. 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
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:
- Parasternal long axis
- Parasternal short axis
- Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed
- EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)
- Left ventricular (LV) mass approximation by septal thickness
- Left Ventricular Chamber Size by internal diameter at diastole
Score each finding based on degree of abnormalities and number of sites with abnormalities

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 9, 2020
Registry last updated: Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed