We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predicting Outcomes for Covid-19 Using Sonography (POCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384055
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
COVID-19 Pneumonia, Viral 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predicting Outcomes for Covid-19 Using Sonography
Actual Study Start Date : March 21, 2020
Actual Primary Completion Date : November 15, 2021
Actual Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of Patients Requiring Mechanical Ventilation [ Time Frame: 28 days from initial evaluation ]
  2. Number of Patients Requiring Supplemental Oxygen Usage [ Time Frame: 28 days from initial evaluation ]
  3. Duration of Supplemental Oxygen Usage [ Time Frame: 28 days from initial evaluation ]
  4. Length of Stay [ Time Frame: 28 days from initial evaluation ]
    Duration of Hospitalization (days)

  5. Characterization of Ultrasound Findings [ Time Frame: 28 days from initial evaluation ]
    Descriptive analysis of ultrasound findings in Covid-19


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384055


Locations
Layout table for location information
United States, California
University of California San Francisco
San Francisco, California, United States, 94117
Stanford University
Stanford, California, United States, 95401
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Andre D Kumar, MD, MEd Stanford University
Principal Investigator: Sally Graglia, MD, MPH University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04384055    
Other Study ID Numbers: IRB-55621
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia, Viral
Respiratory Tract Infections
Infections
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases