A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorUniversity of California, Davis
About this trial
Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Motor vehicle collision: greater than 60 mph, ejection, or rollover
Automobile versus pedestrian/bicycle: automobile speed > 25 mph
Falls greater than 20 feet in height
Crush injury to the torso
Trial design
Design model
Parallel
Treatments tested in this trial
Focused Assessment with Sonography for Trauma (FAST) Examination
Diagnostic testA bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.
No Intervention: Standard of Care - Without the FAST Examination
Other interventionParticipants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.
Treatment groups
4,650 Participants
are divided into 2 treatment groupsGroup A: Focused Assessment with Sonography for Trauma (FAST) Examination ArmOther 1 intervention
Group B: No Intervention - Standard of Care - Without the FAST ExaminationOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of abdominal CT scanning
The primary outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Time frame
For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours)2
Rate of delayed or missed or delayed intra-abdominal injuries
The rate of missed or delayed intra-abdominal injuries (IAI) will be identified and reported for any cases with a delay in diagnosis (i.e., patients diagnosed with IAI in the hospital after ED disposition) or missed IAI (IAI diagnosed after discharge from the ED/hospital).
Time frame
In hospitalized participants, IAI collection will be captured from the time of assignment until discharge (up to 30 days). For participants discharged from the ED IAI collection will be captured from the time of assignment until 7 days after ED discharge3
Identifying variables associated with obtaining abdominal CT scans in very low risk patients with normal FAST examinations
This primary outcome will be a binary indicator (yes/no) for whether the patient with a normal FAST examination who is thought by the clinician to have less than a 1% risk of intra-abdominal injury nonetheless undergoes abdominal CT (outcome of interest).
Time frame
The binary indicator assessment of yes/no will occur upon discharge from the Emergency Department or admission to the hospital, an average of 6.5 hoursSecondary outcomes
1
Emergency Department (ED) length of stay
ED length of stay is a continuous variable measured in minutes. The investigators will compare the ED length of stay between study arms using nonparametric methods (time from ED arrival to hospital admission or time from ED arrival until ED discharge).
Time frame
ED length of stay will be calculated in minutes from the time of ED arrival until the time of ED discharge or the time from ED arrival until the time of hospital admission assessed up to 7 days.2
Rate of Hospitalization
Rate of hospitalization is a categorical variable (yes/no) on whether the patient is hospitalized on initial, enrolling ED visit. The investigators will compare the rate of hospitalization between study arms using categorical statistical methods.
Time frame
The assessment of the categorical variable yes/no will occur upon the participants discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours3
Physician suspicion of intra-abdominal injury
Physician suspicion of intra-abdominal injury is collected after initial physician evaluation for all patients. For those patients who are randomized to the FAST examination this information is collected again after completing the FAST examination. Physician suspicion is collected as follows: Less than 1%, 1-5%, 6-10%, 11-50%, greater than 50%.
Time frame
All physician suspicion assessments will occur up to 24 hours after a participants ED presentation4
Rate of abdominal CT scanning in children 0 to 3 years of age.
In this prespecified age group, the outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Time frame
For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
Pediatric Emergency Care Applied Research Network
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov