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

NCT04340479 | Completed

• 1 other identifier: 20-0751
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID; Trauma; Ultrasound

Keywords

COVID; Trauma; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Correlation of FAST+ pulmonary findings with active COVID infection

  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.

  12 months

Secondary Outcomes (1)

• Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients

  12 months

Study Arms (2)

Absent lung ultrasound findings of active COVID infection

Absence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts

Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation

Present lung ultrasound findings of active COVID infection

Presence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts

Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation

Interventions

Ultrasound lung imaging as part of FAST+ evaluation DIAGNOSTIC_TEST

FAST+ evaluations will expand on the traditional FAST exam to systematically survey bilateral lung fields. Traditional FAST evaluation will survey the perihepatic, perisplenic, pelvic, and pericardial areas. Representative images will be saved by the performing provider for further evaluation. Up to sixteen areas in total will be included in FAST+ evaluation: 1. Anterior midclavicular right and left (apical, medial, basal) 2. Posterior paraspinal right and left\* (apical, medial, basal) \*Posterior lung evaluation will be omitted if patients are at risk for further traumatic injury from repeated side rolling. 3. Lateral axillary medial right and left (apical and basal) Specifically, we will document the presence or absence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts in these lung fields by ultrasound and will record these findings.

Absent lung ultrasound findings of active COVID infection; Present lung ultrasound findings of active COVID infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All trauma patients evaluated at our institution that present as a trauma activation or alerts will be included in the study.

Inclusions: 1. Trauma patients presenting to our institution as trauma activation 2. Trauma patients presenting to our institution as trauma alerts Exclusions: 1. Patients who require prompt surgical exploration based on physical exam findings (minimize delays in transport to the operating room) 2. Patients with an open chest injury

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jose L Diaz-Miron, MD

  University of Colorado/Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: July 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)