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

University of Minnesota (UMN)

Status: Completed

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

Treatments: Diagnostic Test: Point-of-Care Ultrasonography (POCUS)

Study type: Observational

Funder types: Other

Identifiers

NCT04339998

GIM-2020-28740

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

129 participants in 1 patient group

Patients with Suspected or Confirmed COVID-19

Description:

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

Treatment:

Diagnostic Test: Point-of-Care Ultrasonography (POCUS)