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.

项目概要/摘要 腹内损伤（IAI）引起的出血是儿童创伤性死亡的主要原因。一些 共识小组已将受伤儿童的管理作为研究的高度优先事项。许多孩子与 IAI 症状微妙，诊断困难，漏诊或延迟诊断会导致 发病率增加。有限的科学证据和对缺失 IAI 的担忧相结合，导致 过度使用腹部计算机断层扫描 (CT)。 CT 在诊断 IAI 方面非常准确，可减少 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 扫描也给儿童带来风险，尤其是辐射诱发的恶性肿瘤。 因此，有充分的理由积极评估受伤儿童的 IAI 并限制腹部 CT 仅对那些处于不可忽略风险的人进行评估。腹部超声检查可以帮助集中患者评估 通过这种方式，可能会减少低风险儿童腹部 CT 的使用。重点评估 创伤超声检查 (FAST) 检查使用腹部超声检查来检测是否存在 受伤患者的腹腔内液体。 FAST 检查的使用主要针对受伤的成人 患者和两项针对受伤成人的随机对照试验 (RCT) 表明，评估策略 包括 FAST 在内，可以改善患者护理的多个方面，包括安全地减少腹部 CT 的使用。 然而，关于 FAST 检查的实用性，儿科人群中存在有限且相互矛盾的数据。一个 大型多中心观察性研究表明 FAST 可以安全地减少儿童腹部 CT 的使用 被认为 IAI 风险较低。唯一针对儿童的随机对照试验是一项单中心研究，证明了 FAST 的使用 FAST 阴性后，显着降低了临床医生对 IAI 的怀疑。临床医生数量的减少 然而，怀疑并没有转化为 CT 使用的减少。这些研究的相互矛盾的结果 强烈建议需要进行多中心随机对照试验来明确回答这个关键问题。长- 该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 儿童，从而提高护理质量并降低发病率和死亡率。本次活动的具体目标 建议： 1) 对受伤儿童进行 FAST 检查的随机对照试验，并比较 FAST 检查的频率 FAST 组和非 FAST 组儿童之间的腹部 CT 扫描； 2）确定评估策略 包括 FAST 检查导致的 IAI 漏诊或延迟诊断数量与常规检查相似 没有经过 FAST 检查的策略； 3) 识别与患者、医生和系统相关的因素 在 FAST 阴性后，对临床医生认为 IAI 风险极低的患者进行腹部 CT 扫描 考试。这项研究将在六个不同地点招募大量样本（3,180 名儿童），结果将 为 FAST 检查在躯干钝性创伤儿童中的作用提供明确的证据。