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

躯干钝性创伤儿童腹部超声 (FAST) 的随机对照试验

• 批准号: 10522284
• 负责人: James F. Holmes
• 金额: $ 70.6万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-07 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10522284
• 关键词: Abdomen; Abdominal Injuries; Adult; Applied Research; Caring; Cessation of life; Child; Childhood; Childhood Injury; Clinical; Conflict (Psychology); Consensus; Data; Decision Making; Diagnosis; Emergency Care; Emergency Department evaluation; Emergency research; Enrollment; Evaluation; Frequencies; Hemorrhage; Intra-abdominal; Ionizing radiation; Liquid substance; Malignant Neoplasms; Meta-Analysis; Monitor; Morbidity - disease rate; Multicenter Studies; Observational Study; Operative Surgical Procedures; Patient Care; Patients; Physicians; Population; Quality of Care; Radiation; Radiation exposure; Randomized Controlled Trials; Recording of previous events; Research; Research Priority; Risk; Role; Sample Size; Scanning; Site; Symptoms; System; Trauma; Ultrasonography; X-Ray Computed Tomography; abdominal CT; arm; implementation design; implementation trial; improved; injured; intraperitoneal; mortality; patient safety; pediatric emergency; provider behavior; radiation risk; ultrasound

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.

项目摘要/摘要 腹腔内损伤的出血（IAI）是儿童创伤性死亡的主要原因。一些 共识小组将受伤儿童的管理作为高度研究重点。许多孩子 IAIS具有微妙的症状，使诊断困难，遗体或延迟诊断导致 发病率增加。有限的科学证据和对丢失IAI的关注的结合已导致 过度使用腹部计算机断层扫描（CT）。 CT在诊断IAIS方面高度准确，减少 所需的临床监测水平，是确定手术需求的重要因素 治疗。 CT扫描还为儿童带来了风险，但最著名的是辐射引起的恶性肿瘤。 因此，出现令人信服的理由是积极评估受伤的儿童的IAI和限制腹部CT 对那些不可忽略风险的人进行评估。腹部超声检查可以帮助将患者评估集中在 只是通过潜在地减少低风险儿童中腹部CT使用的方式。专注的评估与 创伤的超声检查（快速）检查使用腹部超声检查来检测 受伤患者的腹膜液体。快速检查的使用主要在受伤的成年人 受伤成年人中的患者和两项随机对照试验（RCT）证明了评估策略 包括快速改善患者护理的多个方面，包括安全减少腹部CT使用。 然而，在快速检查的效用的小儿人群中存在有限和冲突的数据。一个 大型多中心，观察性研究表明，快速安全地减少儿童的腹部CT使用 被认为是IAI的低风险。儿童唯一的RCT是一项单一中心研究，证明了快速使用 迅速下降后，显着降低了临床医生对IAI的怀疑。临床医生的减少 然而，怀疑并未转化为CT使用的减少。这些研究的矛盾结果 强烈建议需要一个多中心的RCT来确定回答这个关键问题。长期 该研究的术语目标是确定适当的评估策略，以优化受伤的护理 儿童，导致护理质量改善，发病率和死亡率降低。这个特定的目的 提案是：1）在受伤儿童中进行快速检查的RCT，并比较 在快速和非快速臂中的儿童之间进行腹部CT扫描； 2）确定评估策略是否 包括快速检查导致IAI的遗体诊断或延迟诊断的数量相比 没有快速检查的策略； 3）确定患者，医师和系统因素 在速度负面后，临床医生认为临床医生的IAI风险非常低的患者中，获得腹部CT扫描 考试。这项研究将在六个不同地点招收大量样本量（3180名儿童），结果将 为快速检查在钝性躯干创伤的儿童中的作用提供明确的证据。