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OpenTrials
Completed

NCT Number: NCT04384055

Predicting Outcomes for Covid-19 Using Sonography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Ultrasound

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: POCUS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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