A randomized controlled trial of abdominal ultrasound (FAST) in children with blunt torso trauma

项目摘要/摘要 腹内损伤出血(IAI)是儿童创伤性死亡的主要原因。几个 共识小组已将受伤儿童的管理列为高度研究优先事项。许多患有癌症的儿童 IAIS有细微的症状，使诊断变得困难，漏诊或延误诊断会导致 发病率增加。有限的科学证据和对失踪的IAIS的担忧相结合，导致了 过度使用腹部计算机断层扫描(CT)。CT对IAIS的诊断具有很高的准确性， 所需的临床监测水平，是决定是否需要手术的重要因素 治疗。然而，CT扫描也会给儿童带来风险，最明显的是辐射诱发的恶性肿瘤。 因此，既要积极评估受伤儿童的IAIS，又要限制腹部CT，这是令人信服的理由。 只对那些面临不可忽视风险的人进行评估。腹部超声检查可帮助集中患者评估 正是以这种方式，潜在地减少了低风险儿童腹部CT的使用。重点评估与 创伤超声检查(FAST)使用腹部超声检查来检测是否存在 损伤患者的腹腔液。快速检查的使用主要是在受伤的成年人中发展起来的 患者和两项针对受伤成人的随机对照试验(RCT)表明，一种评估策略 包括FAST在内，改善了患者护理的多个方面，包括安全地减少腹部CT的使用。 然而，在儿科人群中，关于快速检查的效用存在有限和相互矛盾的数据。一个 大型多中心观察性研究表明FAST安全地减少儿童腹部CT的使用 被认为是IAI的低风险。儿童中唯一的随机对照试验是一项显示快速使用的单中心研究 显著降低了临床医生对空腹阴性后IAI的怀疑。临床医生的这一下降 然而，怀疑并没有转化为CT使用量的减少。这些研究得出了相互矛盾的结果 强烈建议需要一个多中心的随机对照试验来明确回答这一关键问题。长的- 研究的长期目标是确定适当的评估策略，以优化对受伤人员的护理 这有助于改善护理质量，降低发病率和死亡率。这样做的具体目的是 建议：1)对受伤儿童进行快速检查的随机对照试验，比较 腹部CT扫描儿童在快臂和非快臂之间的差异；2)确定是否有评估策略 包括快速检查结果的IAIS的漏诊或延迟诊断的数量与 无需快速检查的策略；以及3)确定与以下各项相关的患者、医生和系统因素 临床医生认为IAI风险非常低的患者在禁食阴性后进行腹部CT扫描 考试。这项研究将在六个不同的地点招募大样本(3180名儿童)，结果将 为快速检查在儿童躯干钝性损伤中的作用提供确凿的证据。

PROJECT SUMMARY/ABSTRACT Hemorrhage from intra-abdominal injuries (IAI) is a leading cause of traumatic deaths in children. Several consensus panels have placed management of injured children as a high research priority. Many children with IAIs have subtle symptoms, making the diagnosis difficult, and missed or delayed diagnoses result in increased morbidity. The combination of limited scientific evidence and concern over missing IAIs has resulted in excessive use of abdominal computed tomography (CT). CT is highly accurate in diagnosing IAIs, decreases the level of clinical monitoring required, and is an important factor in determining the need for surgical treatment. CT scanning also presents risks to children, however, most notably radiation-induced malignancies. Thus, compelling reasons exist to both aggressively evaluate injured children for IAIs and to limit abdominal CT evaluation to just those at non-negligible risk. Abdominal ultrasonography can help focus patient evaluation in just this manner by potentially decreasing abdominal CT use in low risk children. The focused assessment with sonography for trauma (FAST) examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients. Use of the FAST examination has primarily evolved in injured adult patients and two randomized controlled trials (RCT) in injured adults demonstrate that an evaluation strategy including the FAST improves multiple aspects of patient care including safely decreasing abdominal CT use. Limited and conflicting data, however, exist in the pediatric population on the utility of the FAST examination. A large multicenter, observational study suggests FAST safely decreases abdominal CT use in children considered low risk for IAI. The only RCT in children was a single center study that demonstrated FAST use significantly decreased clinician suspicion of IAI following a negative FAST. This decrease in clinician suspicion, however, did not translate to a decrease in CT use. The conflicting results from these studies strongly suggest the need for a multicenter RCT powered to definitively answer this critical question. 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. The specific aims of this proposal are to: 1) perform a RCT of the FAST examination in injured children and compare the frequency of abdominal CT scanning between children in the FAST and non-FAST arms; 2) identify if an evaluation strategy including the FAST examination results in similar numbers of missed or delayed diagnosis of IAIs than a strategy without the FAST examination; and 3) identify patient, physician, and system factors associated with obtaining abdominal CT scans in patients considered very low risk for IAI by the clinician after a negative FAST examination. This study will enroll a large sample size (3,180 children) at six diverse sites, and the results will provide definitive evidence for the role of the FAST examination in children with blunt torso trauma.