Trial Outcomes & Findings for BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury (NCT NCT05025449)
NCT ID: NCT05025449
Last Updated: 2024-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
267 participants
Primary outcome timeframe
1 Day of exam
Results posted on
2024-10-08
Participant Flow
Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia, USA. Participant enrollment began September 30, 2021 and the final study visit occurred on September 14, 2023.
Participant milestones
| Measure |
Non-enhanced FAST Exam Followed by BEFAST Exam
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.
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 is performed and documented. This FAST is distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. Following the FAST exam and using the same machine, a BEFAST exam is performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason is injected into the subject's IV, followed by saline flush. The contrast is 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 AAST criteria.
|
|---|---|
|
Overall Study
STARTED
|
267
|
|
Overall Study
COMPLETED
|
265
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Non-enhanced FAST Exam Followed by BEFAST Exam
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.
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 is performed and documented. This FAST is distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. Following the FAST exam and using the same machine, a BEFAST exam is performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason is injected into the subject's IV, followed by saline flush. The contrast is 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 AAST criteria.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient emergently taken to operating room
|
1
|
Baseline Characteristics
BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury
Baseline characteristics by cohort
| Measure |
Non-enhanced FAST Exam Followed by BEFAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
253 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
160 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
267 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 Day of examPopulation: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
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.
Outcome measures
| Measure |
Non-enhanced FAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam, followed by a Bubble-Enhanced FAST exam.
|
BEFAST Exam
n=265 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving a Bubble-Enhanced FAST exam, following the standard of care Focused Assessment with Sonography for Trauma (FAST) exam.
|
|---|---|---|
|
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives
|
18 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 1 Day of examPopulation: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
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.
Outcome measures
| Measure |
Non-enhanced FAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam, followed by a Bubble-Enhanced FAST exam.
|
BEFAST Exam
n=265 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving a Bubble-Enhanced FAST exam, following the standard of care Focused Assessment with Sonography for Trauma (FAST) exam.
|
|---|---|---|
|
Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives
|
214 Participants
|
216 Participants
|
PRIMARY outcome
Timeframe: 1 Day of examThe 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.
Outcome measures
| Measure |
Non-enhanced FAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam, followed by a Bubble-Enhanced FAST exam.
|
BEFAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving a Bubble-Enhanced FAST exam, following the standard of care Focused Assessment with Sonography for Trauma (FAST) exam.
|
|---|---|---|
|
Number of Enrolled Participants With Successful Exams
|
263 Participants
|
245 Participants
|
PRIMARY outcome
Timeframe: 1 Day of examPopulation: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
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.
Outcome measures
| Measure |
Non-enhanced FAST Exam
n=267 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam, followed by a Bubble-Enhanced FAST exam.
|
BEFAST Exam
n=265 Participants
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving a Bubble-Enhanced FAST exam, following the standard of care Focused Assessment with Sonography for Trauma (FAST) exam.
|
|---|---|---|
|
Percent Agreement Between Raters
|
82.6 percentage of agreement
Interval 77.6 to 86.7
|
76.2 percentage of agreement
Interval 70.7 to 81.0
|
Adverse Events
Non-enhanced FAST Exam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BEFAST Exam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-enhanced FAST Exam
n=267 participants at risk
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam, followed by a Bubble-Enhanced FAST exam.
|
BEFAST Exam
n=265 participants at risk
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving a Bubble-Enhanced FAST exam, following the standard of care Focused Assessment with Sonography for Trauma (FAST) exam.
|
|---|---|---|
|
General disorders
Itchy feet
|
0.00%
0/267 • Information on adverse events was collected beginning at the time of informed consent through completion of both the FAST and BEFAST examinations, on the single day of the study (Day 1). Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
|
0.38%
1/265 • Information on adverse events was collected beginning at the time of informed consent through completion of both the FAST and BEFAST examinations, on the single day of the study (Day 1). Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
|
|
General disorders
Nausea
|
0.00%
0/267 • Information on adverse events was collected beginning at the time of informed consent through completion of both the FAST and BEFAST examinations, on the single day of the study (Day 1). Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
|
0.38%
1/265 • Information on adverse events was collected beginning at the time of informed consent through completion of both the FAST and BEFAST examinations, on the single day of the study (Day 1). Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place