Clinical trial NCT04339998: Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
Official title: Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
COVID
Covid-19
SARS-CoV-2
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age and older under investigation for COVID-19 and those patients that are positive for COVID-19 at UMMC and Bethesda. Informed consent will be obtained from the patient or decision maker prior to study inclusion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: POCUS Score - Lungs
timeFrame: up to 14 days
measure: POCUS Score - Heart
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center (UMMC)
state: Minnesota
city: Saint Paul
country: United States
facility: M Health Fairview Bethesda Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Matthew Yocum, MD
role: PRINCIPAL_INVESTIGATOR
References: