Coronavirus InfectionNCT04339998
Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
An observational study of Coronavirus Infection and COVID, run by University of Minnesota at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, COVID, Covid-19
- What is being tested?
- Point-of-Care Ultrasonography (POCUS)
- How many people
- 129 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients under investigation for COVID-19
- patients that are positive for COVID-19 at UMMC and Bethesda
Who cannot join
- ultrasound contraindication such as overlying skin wound
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Medical Center (UMMC)
Minneapolis, Minnesota, 55455
M Health Fairview Bethesda Hospital
Saint Paul, Minnesota, 55103
About this study
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.
Read the 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.
- Conditions
- Coronavirus Infection, COVID, Covid-19, SARS-CoV-2
- Being tested
- Point-of-Care Ultrasonography (POCUS)
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care Ultrasonography (POCUS)Diagnostic test
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Point-of-Care Ultrasonography (POCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: up to 14 days
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
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start15 Apr 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Yocum, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339998
- Sponsor's protocol ID
- GIM-2020-28740
- Status last verified
- Jan 2023
- First submitted
- 6 Apr 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)
- ClinicalTrials.gov ID
- NCT04339998
- Acronym / sponsor ID
- GIM-2020-28740
- Conditions
- Coronavirus Infection, COVID, Covid-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected or Confirmed COVID-19 | – | Diagnostic Test: Point-of-Care Ultrasonography (POCUS)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients under investigation for COVID-19
- patients that are positive for COVID-19 at UMMC and Bethesda
Key exclusion criteria (1 listed)
- ultrasound contraindication such as overlying skin wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: 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 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 | Diagnostic test | Patients with Suspected or Confirmed COVID-19 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Yocum, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and COVID, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCUS Score - Lungs (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.