The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
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ClinicalTrials.gov Identifier: NCT04340479 |
Recruitment Status :
Completed
First Posted : April 9, 2020
Last Update Posted : September 28, 2021
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Condition or disease | Intervention/treatment |
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COVID Trauma Ultrasound | Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation |
The current coronavirus disease 2019 (COVID-19) pandemic has created a unique situation for initial healthcare providers who strive to provide optimal medical care while minimizing personal exposure in acute scenarios. Although the morbidity and mortality for this disease is low for young healthy individuals, it presents a potentially serious threat to older healthcare providers or those providers with chronic medical conditions. Once a patient arrives emergently to the emergency department (ED) setting, ED providers must act promptly to evaluate these individuals for COVID-19 infection risk factors such as exposure, symptoms, and chronic medical conditions. However, some medical and surgical patients presenting emergently for evaluation are unable to provide a reliable medical history due to age, drugs, the absence of a next of kin, or altered mental status. Acutely traumatized patients often undergo computed tomography of the chest during their comprehensive evaluation. Adding a rapid bedside ultrasound of the chest as a research procedure could allow validation of ultrasound to help stratify medical and surgical patients into high and low risk of COVID-19 categories, with no radiation exposure, and far faster than current COVID-19 diagnostic PCR testing.
Aims: The project proposes to collect data that will inform a novel strategy to mitigate risk to providers by providing early, objective, and rapidly collected end organ data which will permit the stratification of pediatric trauma patients into low or high risk COVID-19 categories. The project will collect and evaluate lung ultrasound (US) findings in an expanded Focused Assessment with Sonography in Trauma (FAST) evaluation of the chest of pediatric trauma patients. The term "FAST+" is used to denote the use of FAST expanded to image the select lung fields in traumatized patients. The researchers hypothesize that FAST+ will result in identification of pulmonary findings indicative of COVID-19 infections and will significantly correlate with the gold standard derived from computed tomography (CT) performed in parallel in these traumatically injured patients.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 53 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation |
Actual Study Start Date : | July 30, 2020 |
Actual Primary Completion Date : | September 1, 2021 |
Actual Study Completion Date : | September 1, 2021 |

Group/Cohort | Intervention/treatment |
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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
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Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation
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:
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. |
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
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:
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. |
- Correlation of FAST+ pulmonary findings with active COVID infection [ Time Frame: 12 months ]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.
- Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients [ Time Frame: 12 months ]Exploratory outcomes will focus on description of additional ancillary findings of the FAST+ examination in those patients who later are determined to be COVID-19 positive compared to those determined to be COVID-19 negative (e.g., patterns of pleural space disease).

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusions:
- Trauma patients presenting to our institution as trauma activation
- Trauma patients presenting to our institution as trauma alerts
Exclusions:
- Patients who require prompt surgical exploration based on physical exam findings (minimize delays in transport to the operating room)
- Patients with an open chest injury

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340479
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Jose L Diaz-Miron, MD | University of Colorado/Children's Hospital Colorado |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT04340479 |
Other Study ID Numbers: |
20-0751 |
First Posted: | April 9, 2020 Key Record Dates |
Last Update Posted: | September 28, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID Trauma Ultrasound |
Wounds and Injuries |