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

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04339998
Collaborator
(none)
129
2
29.5
64.5
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point-of-Care Ultrasonography (POCUS)

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
Actual Enrollment :
129 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with Suspected or Confirmed COVID-19

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

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

Outcome Measures

Primary Outcome Measures

  1. POCUS Score - Lungs [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: 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

  2. POCUS Score - Heart [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: 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Medical Center (UMMC) Minneapolis Minnesota United States 55455
2 M Health Fairview Bethesda Hospital Saint Paul Minnesota United States 55103

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Matthew Yocum, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT04339998
Other Study ID Numbers:
  • GIM-2020-28740
First Posted:
Apr 9, 2020
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022