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

Completed
Conditions
Coronavirus Infection
Covid-19
COVID
SARS-CoV-2
Interventions
Diagnostic Test: Point-of-Care Ultrasonography (POCUS)
Registration Number
NCT04339998
Lead Sponsor
University of Minnesota
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
129
Inclusion Criteria
  • patients under investigation for COVID-19
  • patients that are positive for COVID-19 at UMMC and Bethesda
Read More
Exclusion Criteria
  • ultrasound contraindication such as overlying skin wound
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with Suspected or Confirmed COVID-19Point-of-Care Ultrasonography (POCUS)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
Primary Outcome Measures
NameTimeMethod
POCUS Score - Heartup 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

POCUS Score - Lungsup 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of Minnesota Medical Center (UMMC)

πŸ‡ΊπŸ‡Έ

Minneapolis, Minnesota, United States

M Health Fairview Bethesda Hospital

πŸ‡ΊπŸ‡Έ

Saint Paul, Minnesota, United States

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