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.

项目总结/摘要 腹腔内损伤（IAI）出血是儿童创伤性死亡的主要原因。几 共识小组已将受伤儿童的管理作为一个高度优先的研究事项。许多儿童， IAI有轻微的症状，使诊断困难，漏诊或延误诊断导致 增加发病率。有限的科学证据和对缺失IAI的担忧相结合， 过度使用腹部计算机断层扫描（CT）。CT诊断IAI的准确性高， 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，最明显的是辐射引起的恶性肿瘤。 因此，有充分的理由积极评估IAI的受伤儿童，并限制腹部CT 仅对那些风险不可忽略的人进行评估。腹部超声检查可以帮助重点病人的评价， 通过潜在地减少低风险儿童中腹部CT的使用。重点评估， 创伤超声检查（FAST）使用腹部超声检查来检测是否存在 受伤病人的腹腔积液。FAST检查的使用主要是在受伤的成年人中进行的 患者和两个随机对照试验（RCT）在受伤的成年人证明，一个评估策略， 包括FAST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，儿科人群中关于FAST检查实用性的数据有限且相互矛盾。一 一项大型多中心观察性研究表明，FAST可安全减少儿童腹部CT的使用 IAI的风险较低。唯一的儿童随机对照试验是一项证明了FAST使用的单中心研究 显著降低了临床医生对阴性FAST后IAI的怀疑。临床医生减少 然而，怀疑并没有转化为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随机对照试验来明确回答这个关键问题。很长的- 本研究的长期目标是确定适当的评估策略，以优化受伤者的护理 这一举措有助于提高儿童的护理质量，降低发病率和死亡率。具体目标是 建议：1）在受伤儿童中进行FAST检查的RCT，并比较 FAST组和非FAST组儿童之间的腹部CT扫描; 2）确定评估策略是否 包括FAST检查结果在内，IAI的漏诊或延迟诊断的数量与 无FAST检查的策略;以及3）确定与以下因素相关的患者、医生和系统因素： 在FAST阴性后，获得临床医生认为IAI风险极低的患者的腹部CT扫描 考试这项研究将在六个不同的地点招募大样本量（3，180名儿童），结果将 为FAST检查在儿童钝性躯干创伤中的作用提供明确的证据。