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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339998
• Other study ID #: GIM-2020-28740
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID
• Covid-19
• SARS-CoV-2

Intervention

Diagnostic Test:
• 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: 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

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center (UMMC)	Minneapolis	Minnesota
United States	M Health Fairview Bethesda Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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	up to 14 days
Primary	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: 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	up to 14 days