Predicting Outcomes for Covid-19 Using Sonography (POCUS)

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 Covid-19 pneumonia or patients at risk for deterioration early in the disease course.

Study Overview

• Status: Completed
• Conditions: COVID-19; Pneumonia, Viral
• Intervention / Treatment: Diagnostic test: Lung Ultrasound

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: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • University of California San Francisco
    • Stanford, California, United States, 95401
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This population will include all persons under investigation (PUIs) for covid-19 presenting to the Stanford emergency department.

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?

Number of groups / cohorts

2

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	Diagnostic test: Lung Ultrasound; Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
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.	Diagnostic test: Lung Ultrasound; 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	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		28 days from initial evaluation
Number of Patients Requiring Supplemental Oxygen Usage		28 days from initial evaluation
Duration of Supplemental Oxygen Usage		28 days from initial evaluation
Length of Stay	Duration of Hospitalization (days)	28 days from initial evaluation
Characterization of Ultrasound Findings	Descriptive analysis of ultrasound findings in Covid-19	28 days from initial evaluation

Collaborators and Investigators

• Sponsor: Stanford University
• 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): March 21, 2020
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): November 15, 2021

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Pneumonia, Viral
• Other Study ID Numbers: IRB-55621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No