Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial.
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BACKGROUND: Hemorrhage from intra-abdominal injuries (IAI) is a leading cause of traumatic deaths in children. Concern over misdiagnosing IAIs has resulted in excessive use of abdominal computed tomography (CT). Despite its many benefits, CT presents risks to children most notably radiation-induced malignancies. Thus, we must safely limit abdominal CT evaluation to those at non-negligible risk. The focused assessment with sonography for trauma (FAST) examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients and may decrease abdominal CT use in some children. Limited and conflicting data exists on the utility of the FAST examination in children. A large multicenter study is thus necessary to determine if the FAST examination should routinely be included in the diagnostic evaluation of injured children. METHODS: This is a multicenter, randomized controlled clinical trial to assess the impact of the FAST examination on the initial evaluation of children with blunt abdominal trauma. Enrolled participants will be randomized 1:1 to the FAST examination plus routine care or routine care alone during their initial emergency department (ED) evaluation. The study will enroll 3194 (initial sample size) to 4346 (second sample size) children at six diverse sites. The primary outcomes are as follows: (1) The proportion of abdominal CT in the initial 24 h of care and (2) the proportion of missed or delayed diagnoses of IAIs. Secondary outcomes include (1) ED length of stay, (2) hospitalization proportion and length of hospital stay, (3) physician suspicion of IAI, (4) the proportion of abdominal CT use in the subgroup of children 0 to 3 years old, and (5) laparotomy proportion. Hospitalized participants will be followed through their stay, and guardians of those discharged from the ED will be contacted after 1 week to assess their status. DISCUSSION: The study will determine if the FAST examination results in a safe reduction of CT use in injured children and will provide definitive evidence if the FAST examination should be routinely implemented in the initial evaluation of children with blunt abdominal trauma. TRIAL REGISTRATION: ClinicalTrials.gov NCT05910567. Registered on May 9, 2023.