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NCT04340479 · ClinicalTrials.gov registry record

The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

A clinical trial, sponsored by University of Colorado, Denver.

Completed
Registry status
53
Enrollment target

NCT04340479: Completed study, sponsored by University of Colorado, Denver.

NCT04340479 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04340479 has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
53 participants
Enrollment target

Study Summary

The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.

Primary Outcome

Will correlate FAST+ pulmonary findings and published CT findings noted in active COVID infection to determine if FAST+ is a suitable diagnostic tool in detecting active COVID infection. Plan to use FAST+ imaging findings to stratify patients into low or high-risk COVID-19 infection groups.

Interventions

  • DIAGNOSTIC_TEST Ultrasound lung imaging as part of FAST+ evaluation

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2020-07-30
Est. Completion 2021-09-01
University of Colorado, Denver

1,283 total trials

What the finished NCT04340479 record still lists

NCT04340479 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Ultrasound lung imaging as part of FAST+ evaluation is the first listed.

NCT04340479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04340479 about?

NCT04340479 is a clinical study titled "The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation". The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing...

What is the current status of trial NCT04340479?

This trial is currently completed. The enrollment target is 53 participants. The study started on 2020-07-30. Estimated completion is 2021-09-01.

What interventions are being tested in trial NCT04340479?

The interventions under investigation include: Ultrasound lung imaging as part of FAST+ evaluation (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04340479?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04340479, the US trial registry maintained by the National Library of Medicine. NCT04340479 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.