Wounds and Injuries Clinical Trial
— FASTOfficial title:
A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
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.
Status | Recruiting |
Enrollment | 3194 |
Est. completion date | April 30, 2027 |
Est. primary completion date | April 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria. Inclusion Criteria: 1. Blunt torso trauma resulting from a significant mechanism of injury: - 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 - Physical assault involving the abdomen 2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma 3. Blunt traumatic event with any of the following (regardless of the mechanism): - Extremity paralysis - Multiple long bone fractures (e.g., tibia and humerus fracture) 4. History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above) Exclusion Criteria: The following patients will be excluded from the study: 1. Age-adjusted low blood pressure (Hemodynamic instability) - Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years. 2. Penetrating trauma: Patients who are victims of stab or gunshot wounds 3. Traumatic injury occurring > 24 hours prior to the time of presentation to the ED 4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed 5. Transferred with FAST exam already performed at outside hospital 6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts 7. Initial GCS score = 8 as it is standard for children with GCS scores = 8 to undergo abdominal CT if blunt abdominal trauma is suspected 8. Known pregnancy 9. Known prisoner 10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | University of Colorado, Anschutz Medical Center and Children's Hospital Colorado | Aurora | Colorado |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | The Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of California, Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
James F. Holmes, MD, MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Emergency Care Applied Research Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours) | |
Primary | 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). | 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 discharge | |
Primary | 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). | 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 hours | |
Secondary | 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). | 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. | |
Secondary | 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. | 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 hours | |
Secondary | 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%. | All physician suspicion assessments will occur up to 24 hours after a participants ED presentation | |
Secondary | 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). | For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours). | |
Secondary | Laparotomy (surgery to the abdomen) rate | Laparotomy rate is a binary indicator (yes/no) for whether the patient underwent a laparotomy (surgery to the abdomen) to identify/repair an intra-abdominal injury. | For the first seven days after the time of injury. |
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