COVIDNCT04340479
The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
An observational study of COVID and Trauma, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID, Trauma, Ultrasound
- What is being tested?
- Ultrasound lung imaging as part of FAST+ evaluation
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 1 Sep 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All trauma patients evaluated at our institution that present as a trauma activation or alerts will be included in the study.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
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.
- Conditions
- COVID, Trauma, Ultrasound
- Being tested
- Ultrasound lung imaging as part of FAST+ evaluation
- Keywords
- COVID, Trauma, Ultrasound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound lung imaging as part of FAST+ evaluationDiagnostic 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:
- Anterior midclavicular right and left (apical, medial, basal)
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start30 Jul 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose L Diaz-Miron, MD, Principal investigator, University of Colorado/Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340479
- Sponsor's protocol ID
- 20-0751
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
- ClinicalTrials.gov ID
- NCT04340479
- Acronym / sponsor ID
- 20-0751
- Conditions
- COVID, Trauma, Ultrasound
- Keywords
- COVID, Trauma, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absent lung ultrasound findings of active COVID infection | – | Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluationAbsence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts |
| Present lung ultrasound findings of active COVID infection | – | Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluationPresence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All trauma patients evaluated at our institution that present as a trauma activation or alerts will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound lung imaging as part of FAST+ evaluationFAST+ 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. | Diagnostic test | Absent lung ultrasound findings of active COVID infection, Present lung ultrasound findings of active COVID infection |
Primary outcome
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.
1 secondary outcome
Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Diaz-Miron, MD principal investigator
University of Colorado/Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Trauma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of FAST+ pulmonary findings with active COVID infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.