Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
Overview
- Phase
- Phase 4
- Intervention
- Contrast-Enhanced Ultrasound using Lumason
- Conditions
- Abdominal Injuries
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.
Detailed Description
Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed. This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Contrast-Enhanced Ultrasound using Lumason
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
Intervention: Contrast-Enhanced Ultrasound using Lumason
Outcomes
Primary Outcomes
Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
Time Frame: 2 years
To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
Time Frame: 2 years
To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.