POCUS: Predicting Outcomes for Covid-19 Using Sonography

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04384055
Collaborator
(none)
165
2
19.8
82.5
4.2

Study Details

Study Description

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 Phase
  • 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

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 :
Mar 21, 2020
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula [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 [28 days from initial evaluation]

  2. Number of Patients Requiring Supplemental Oxygen Usage [28 days from initial evaluation]

  3. Duration of Supplemental Oxygen Usage [28 days from initial evaluation]

  4. Length of Stay [28 days from initial evaluation]

    Duration of Hospitalization (days)

  5. Characterization of Ultrasound Findings [28 days from initial evaluation]

    Descriptive analysis of ultrasound findings in Covid-19

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94117
2 Stanford University Stanford California United States 95401

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Andre D Kumar, MD, MEd, Stanford University
  • Principal Investigator: Sally Graglia, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT04384055
Other Study ID Numbers:
  • IRB-55621
First Posted:
May 12, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021