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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

Tracking Information
First Submitted Date May 8, 2020
First Posted Date May 12, 2020
Last Update Posted Date December 3, 2021
Actual Study Start Date March 21, 2020
Actual Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2020)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2020)
  • Number of Patients Requiring Mechanical Ventilation [ Time Frame: 28 days from initial evaluation ]
  • Number of Patients Requiring Supplemental Oxygen Usage [ Time Frame: 28 days from initial evaluation ]
  • Duration of Supplemental Oxygen Usage [ Time Frame: 28 days from initial evaluation ]
  • Length of Stay [ Time Frame: 28 days from initial evaluation ]
    Duration of Hospitalization (days)
  • Characterization of Ultrasound Findings [ Time Frame: 28 days from initial evaluation ]
    Descriptive analysis of ultrasound findings in Covid-19
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Outcomes for Covid-19 Using Sonography
Official Title Predicting Outcomes for Covid-19 Using Sonography
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID-19
  • Pneumonia, Viral
Intervention Diagnostic Test: Lung Ultrasound
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: Lung Ultrasound
  • 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.
    Intervention: Diagnostic Test: Lung Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 1, 2021)
165
Original Estimated Enrollment
 (submitted: May 8, 2020)
200
Actual Study Completion Date November 15, 2021
Actual Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04384055
Other Study ID Numbers IRB-55621
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Stanford University
Original Responsible Party Same as current
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Andre D Kumar, MD, MEd Stanford University
Principal Investigator: Sally Graglia, MD, MPH University of California, San Francisco
PRS Account Stanford University
Verification Date December 2021