CEUS for Blunt Abdominal Trauma in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 7/20/2018 |
| Start Date: | June 1, 2018 |
| End Date: | May 31, 2021 |
| Contact: | Aaron E Chen, MD |
| Email: | chena2@email.chop.edu |
| Phone: | 2674260383 |
Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for
intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure,
costs, and need for transport. Contrast enhanced ultrasonography has recently shown some
promise as a way to detect intra-abdominal organ injury and may be able to replace the need
for conventional CT scanning, without the need for ionizing radiation and the ability to be
performed at the bedside.
intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure,
costs, and need for transport. Contrast enhanced ultrasonography has recently shown some
promise as a way to detect intra-abdominal organ injury and may be able to replace the need
for conventional CT scanning, without the need for ionizing radiation and the ability to be
performed at the bedside.
In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the
gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT
include risks due to radiation exposure and necessity of transport of the patient. Ultrasound
without contrast uses safer non-ionizing radiation and can be performed at the bedside,
however it has been shown to have variable sensitivity and specificity for identifying
intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have
shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as
compared to a gold standard conventional CT scan for the identification of intra-abdominal
solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific
Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the
detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in
hemodynamically stable children with blunt abdominal trauma
Design:
This will be a prospective cohort study to evaluate the test characteristics of contrast
enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in
children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects
will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for
whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the
ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or
acquired heart disease. Sample size calculations assume a baseline prevalence of disease in
approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95%
with a two-sided confidence interval precision of 8%, yielding an estimated sample size of
146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS
as compared to a gold standard CT scan.
gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT
include risks due to radiation exposure and necessity of transport of the patient. Ultrasound
without contrast uses safer non-ionizing radiation and can be performed at the bedside,
however it has been shown to have variable sensitivity and specificity for identifying
intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have
shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as
compared to a gold standard conventional CT scan for the identification of intra-abdominal
solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific
Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the
detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in
hemodynamically stable children with blunt abdominal trauma
Design:
This will be a prospective cohort study to evaluate the test characteristics of contrast
enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in
children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects
will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for
whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the
ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or
acquired heart disease. Sample size calculations assume a baseline prevalence of disease in
approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95%
with a two-sided confidence interval precision of 8%, yielding an estimated sample size of
146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS
as compared to a gold standard CT scan.
Inclusion Criteria:
1. Hemodynamically stable (defined as not needing massive transfusion protocol and not
undergoing an emergent surgical procedure within the next hour)
2. History of or suspicion for blunt abdominal trauma
3. Abdominal CT ordered or obtained
Exclusion Criteria:
1. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride
lipid microsphere components, or other ingredients in Lumason (polyethylene glycol,
distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium
(DPPG-Na), palmitic acid)
2. Co-existing penetrating abdominal trauma
3. Known congenital or acquired heart disease
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-0383
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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