Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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