Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 129
- Locations
- 2
- Primary Endpoint
- POCUS Score - Heart
Study Overview
Brief Summary
Specific Aims:
- 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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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: 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 - 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: 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 Outcomes
No secondary outcomes reported