Predicting Outcomes for Covid-19 Using Sonography (POCUS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As Covid-19 continues to stress hospital-based resources (including personal protective equipment, ancillary staff availability, and imaging study utilization), it is important to assess whether alternative methods for evaluating patients can be utilized to appropriately triage and care for Covid-positive patients. Current limitations of caring for patients with Covid-19 include the exposure of ancillary healthcare workers (including radiological technicians) and the time/resources required to decontaminate traditional radiological equipment such as x-ray or computerized tomography (CT) machines.
Point-of-care ultrasound (POCUS) has the potential to transform healthcare delivery due to its diagnostic and therapeutic expediency. It can be quickly performed at the bedside by experienced clinicians. It it has been shown to reliably and accurately diagnose patients with a variety of lung diseases, including pneumonia. This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify the virus or patients at risk for deterioration early in the disease course. Moreover, it has the potential to reduce the need for x-rays or CTs for Covid-19 patients, which has the potential to alleviate a significant burden currently being placed on the healthcare system.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94117
- University of California San Francisco
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Stanford, California, United States, 95401
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any adult (18 or more years of age) presenting to the emergency department with symptoms suspicious for Covid-19
- This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
- This individual received a lung ultrasound by the study authors within 28 days from initial evaluation
Exclusion Criteria:
- Any individual who did not receive a lung ultrasound within 28 days from initial evaluation for covid-19 related illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Covid-19 Positive Patients
This group includes individuals who were diagnosed with Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx
|
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
|
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Covid-19 Negative Patients
This group includes individuals who did NOT have a positive test for Covid-19 based on reverse transcriptase polymerase chain reaction (RT-PCR) of the nasopharynx.
|
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula
Time Frame: 28 days from initial evaluation
|
Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)
|
28 days from initial evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients Requiring Mechanical Ventilation
Time Frame: 28 days from initial evaluation
|
28 days from initial evaluation
|
|
|
Number of Patients Requiring Supplemental Oxygen Usage
Time Frame: 28 days from initial evaluation
|
28 days from initial evaluation
|
|
|
Duration of Supplemental Oxygen Usage
Time Frame: 28 days from initial evaluation
|
28 days from initial evaluation
|
|
|
Length of Stay
Time Frame: 28 days from initial evaluation
|
Duration of Hospitalization (days)
|
28 days from initial evaluation
|
|
Characterization of Ultrasound Findings
Time Frame: 28 days from initial evaluation
|
Descriptive analysis of ultrasound findings in Covid-19
|
28 days from initial evaluation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andre D Kumar, MD, MEd, Stanford University
- Principal Investigator: Sally Graglia, MD, MPH, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-55621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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