BEdside Exclusion of Pulmonary Embolism in children without Radiation (BEEPER)

未接受放射治疗的儿童肺栓塞的床位排除 (BEEPER)

• 批准号: 10444005
• 负责人: ANGELA M ELLISON
• 金额: $ 118.82万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10444005
• 关键词: BEdside; Exclusion; Pulmonary; Embolism; children

Abstract No study has been performed to prospectively record the presenting complaints, signs, symptoms and comorbidities of children who raised the suspicion of pulmonary embolism (PE) in children. Clinicians must extrapolate what is known about PE in adults to children. This process puts children in harm’s way: most children with PE go undiagnosed after their first contact with a healthcare provider, meaning diagnosis is often delayed. Perhaps as a result, the mortality rate of PE is the same in children as it is in adults. On the other hand, tens of thousands of low risk children and adolescents are unnecessarily exposed to increased lifetime cancer risk from ionizing radiation from CT scans done to search for PE they do not have. No clinical criteria have been developed to either estimate the probability of PE in children, or to exclude PE based upon information available at the bedside. In adults, the Pulmonary Embolism Rule out Criteria, or PERC rule, has been validated as a method to exclude PE. In this work, we will test a modification of the PERC rule, PERC- Peds, which uses an age adjustment to heart rate, one of the 8 objective criteria in the PERC rule. This project will prospectively test if PERC-Peds, can safely exclude PE in 4,030 children aged 5-17 who raise a suspicion of PE in the emergency department setting. The criterion standard outcome is diagnosis of PE or DVT within 45 days. To reach the study-defined threshold of safety, the top limit of the 95% confidence interval for the false negative rate of the exclusionary criteria (PERC-Peds) must be lower than 1.5%. Additionally, we will test the diagnostic accuracy of the D-dimer, in the subset of patients with the test ordered as part of usual care, and data will be collected for multiple other ancillary aims. This project will also identify which factors truly increase or decrease the probability of PE outcome in children who raise a suspicion of PE, and may provide a much needed evidence basis for physicians to have a rational basis to launch a workup for PE, and also provide clinical criteria to exclude PE without the need for ionizing radiation.

抽象的 尚未进行研究来前瞻性地记录出现的主诉、体征、症状和 临床医生必须对怀疑患有肺栓塞（PE）的儿童进行诊断。 将有关成人早泄的知识推断到儿童身上：这个过程会让儿童受到伤害。 患有肺栓塞的儿童在第一次与医疗保健提供者联系后并未得到诊断，诊断的意义通常是 或许正因如此，儿童肺栓塞的死亡率与成人相同。 另一方面，数以万计的低风险儿童和青少年不必要地延长了寿命 为了寻找 PE 而进行的 CT 扫描产生的电离辐射有癌症风险，但他们没有临床标准。 已开发用于估计儿童 PE 的概率，或根据以下情况排除 PE 在成人中，肺栓塞排除标准（PERC 规则）具有床边可用的信息。 已被验证为一种排除 PE 的方法。在这项工作中，我们将测试 PERC 规则的修改，PERC-。 Peds，使用心率年龄调整，这是 PERC 规则中的 8 个客观标准之一。 将前瞻性测试 PERC-Peds 是否可以安全排除 4,030 名 5-17 岁提出怀疑的儿童中的 PE 急诊科环境中 PE 的标准结果是诊断为 PE 或 DVT。 45 天达到研究定义的安全阈值，即 95% 置信区间的上限。 排除标准（PERC-Peds）的假阴性率必须低于1.5% 此外，我们将进行测试。 作为常规护理一部分进行测试的患者子集中 D-二聚体的诊断准确性，以及 该项目还将为多个其他辅助目标收集数据，以确定哪些因素真正增加。 或降低怀疑患有肺栓塞的儿童发生肺栓塞结果的可能性，并可能提供更多帮助 医生需要证据基础才能有合理的基础来开展 PE 检查，并提供 无需电离辐射即可排除 PE 的临床标准。