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

Summary

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.

Conditions

• Abdominal Trauma

Interventions

DIAGNOSTIC_TEST

Focused Assessment with Sonography for Trauma (FAST)

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam.

DRUG

Bubble-Enhanced FAST (BEFAST)

Following the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by the American Association for the Surgery of Trauma (AAST) criteria.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Emory University

  lead OTHER

Principal Investigators

• Laura Oh, MD · Emory University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-30

Primary Completion

2023-09-14

Completion

2023-09-14

FDA Drug

Yes

Countries

• United States

Study Locations