Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Condition: Abdominal Trauma
MeSH terms: Wounds and Injuries; Abdominal Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The research protocol aims to compare the utility of contrast enhanced abdominal sonography
      with computerized tomography in the evaluation of children with blunt abdominal trauma.
      Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the
      trauma service with a CT scan of abdomen & pelvis already performed at the referring
      institution will be identified by the trauma service as eligible for inclusion.

      The ultrasounds will be performed by one of two Attending Radiologists involved in the study.
      The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is
      an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in
      echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal
      and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist.
      Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be
      redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be
      monitored for 30 minutes after the contrast agent is given and any adverse reactions will be
      recorded. Adverse reactions to Optison have occurred within this time frame in the
      literature. Subsequent medical care will be as indicated per the clinical practice guideline.
    

Detailed description: 
      Contrast enhanced ultrasound has been used clinically in Europe for the past 10 years as an
      evaulation tool for examining abdominal injuries in trauma among children and adults. This is
      a valuable diagnostic modality that could potentially reduce the need for radiation exposure
      from abdominal computed tomography (CT) scans in trauma evaluation. The research protocol
      aims to compare the utility of contrast enhanced abdominal sonography with computerized
      tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable
      children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT
      scan of abdomen & pelvis already performed at the referring institution will be identified by
      the trauma service as eligible for inclusion. Children who are hemodynamically unstable,
      known cardiac abnormality, unable to roll over, or unable to assent will be excluded from the
      study. If the child is enrolled in the study, he/she will have a non contrast ultrasound,
      followed by a contrast enhanced ultrasound performed in the Radiology Department once he/she
      is stabilized and evaluation is completed in the Emergency Room. The patient will have vital
      signs (including blood pressure, heart rate, respiratory rate, oxygen saturation) monitored
      during the study and 30 minutes after contrast administration.

      The ultrasounds will be performed by one of two Attending Radiologists involved in the study.
      The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is
      an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in
      echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal
      and pelvic solid tumors. After the non contrast ultrasound is performed, the Optison contrast
      agent will be given via peripheral IV. The contrast enhanced ultrasound will be performed by
      radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison
      will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs
      will be monitored for 30 minutes after the contrast agent is given and any adverse reactions
      will be recorded. Adverse reactions to Optison have occurred within this time frame in the
      literature. Subsequent medical care will be as indicated per the clinical practice guideline.
    

Intervention name(s): Contrast enhanced Ultrasound
Intervention type(s): Drug
Intervention description(s): Ultrasound, then contrast enhanced ultrasound.
Other intervention name(s): Optison
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pediatric Abdominal Trauma Ultrasound Contrast