The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted
as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for
identifying solid organ injury in the absence of hemoperitoneum is a significant
limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly
enhance the evaluation of the trauma patient with acute intra-abdominal injury through
the use of intravascular microbubbles that allow direct visualization of lacerations to
solid organs. European studies have demonstrated that ultrasound contrast markedly
improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is
performed in the radiology suite. The researchers hypothesize that the bubble-enhanced
FAST or BEFAST exam will be more sensitive than traditional FAST for identification of
solid organ injury in hemodynamically stable blunt abdominal trauma patients when
performed by emergency providers.

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury

Abdominal Trauma

Blunt abdominal trauma, whether from motor vehicle crash, assault, fall, or recreational
injury, is a leading cause of morbidity and mortality. According to the 2016 National
Trauma Database, 12% of all patients with trauma admissions had abdominal trauma, the
majority of which is blunt. The diagnosis of intra-abdominal injury due to blunt
abdominal trauma can be challenging. The physical exam is unreliable in patients with
altered mental status or with impairment due to drugs or alcohol. While computed
tomography (CT) can rapidly and accurately diagnose injury, emergency physicians have
raised concerns that the use of CT has become overly liberal. The risks of
overutilization of CT in hemodynamically stable blunt abdominal trauma include increased
health care costs, lengthy stays in the emergency department, risks of contrast-induced
nephropathy and radiation-induced malignancy, and patient anxiety when "incidentalomas"
are discovered that need extensive and often unnecessary workup.

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted
as part of the advanced trauma life support (ATLS) protocol, but its low sensitivity for
identifying solid organ injury in the absence of hemoperitoneum is a significant
limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly
enhance the evaluation of the trauma patient with acute intra-abdominal injury through
the use of intravascular microbubbles that allow direct visualization of lacerations to
solid organs.

In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride
lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both
adult and pediatric patients, opening new areas of research in the United States. Lumason
is a second generation contrast agent that is more stable than previous ultrasound
contrast agents and does not require refrigeration. Although approved for intravascular
and intravesical use, Lumason's use in a trauma exam is off-label in the United States.

After participants provide informed consent, a baseline FAST exam will be performed and
documented. This exam will be distinct from the initial ATLS resuscitation FAST in order
to avoid any interference in the trauma evaluation. If not already placed, an intravenous
line will be established according to standard practice for trauma patients. Following
the FAST exam, a bubble-enhanced FAST (BEFAST) exam will be performed using Lumason as
the contrast agent. As part of the standard of care, participants will have a CT exam
performed within 24 hours, which will provide the gold standard for diagnosis of solid
organ trauma.

Focused Assessment with Sonography for Trauma (FAST)

Bubble-Enhanced FAST (BEFAST)

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma

The performance of the study exams will be assessed as the number of correctly identified
solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence
of injury will be determined by the gold standard of a CT exam, conducted within 24 hours
as part of the standard of care.

The performance of the study exams is assessed as the percentage of correctly identified
lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The
presence of solid organ injury is determined by the gold standard of a CT exam, conducted
within 24 hours as part of the standard of care.

The number of successful, completed exams is used to determine whether emergency
physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered
complete if the participant tolerates the study without experiencing severe adverse
events to contrast and the participant allows the provider to complete the scan, and if
the exam results in images of adequate quality to answer the focused clinical question.

Emergency physicians' interpretations of the ultrasound exams are compared to
interpretations of board-certified radiologists for the presence or absence of solid
organ injury, free fluid, or active extravasation. Injured organs are graded per American
Association for the Surgery of Trauma (AAST) criteria.

Associate Professor

Participants in the emergency department with hemodynamically stable blunt abdominal
trauma will receive the standard of care Focused Assessment with Sonography for Trauma
(FAST) exam followed by a Bubble-Enhanced FAST exam.

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury

About this trial

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Placebo

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