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Predicting Outcomes for Covid-19 Using Sonography

NCT ID: NCT04384055

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-21

Study Completion Date

2021-11-15

Brief Summary

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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

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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.

Conditions

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COVID-19 Pneumonia, Viral

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DIAGNOSTIC_TEST

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.

Lung Ultrasound

Intervention Type DIAGNOSTIC_TEST

Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.

Interventions

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Lung Ultrasound

Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre D Kumar, MD, MEd

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sally Graglia, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-55621

Identifier Type: -

Identifier Source: org_study_id