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

摘要 没有进行任何研究来前瞻性地记录出现的主诉、体征、症状和 引起怀疑为儿童肺栓塞(PE)的儿童的合并症。临床医生必须 把成年人对体育的了解外推到儿童身上。这一过程将儿童置于危险的境地：大多数 患有PE的儿童在第一次与医疗保健提供者接触后没有得到诊断，这意味着诊断通常是 延迟了。或许正因为如此，儿童的PE死亡率与成人的死亡率相同。另一方面 另一方面，数以万计的低风险儿童和青少年不必要地暴露在延长的寿命中 CT扫描的电离辐射的癌症风险，这些扫描是为了寻找他们没有的PE而进行的。没有临床标准 已经开发出要么估计儿童发生PE的可能性，要么基于以下因素排除PE 可在床边查看相关信息。在成年人中，肺栓塞排除标准，或PERC规则， 被证实是排除PE的一种方法。在这项工作中，我们将测试对PERC规则的修改，PERC- 使用心率的年龄调整，这是PERC规则中的8个客观标准之一。这个项目 将前瞻性地测试PERC-PEDS，是否可以安全地将4,030名5-17岁提出怀疑的儿童排除PE 急诊科环境中的体育课。标准的结果是诊断的PE或DVT 45天。为了达到研究定义的安全阈值， 排除标准(PERC-PEDS)的假阴性率必须低于1.5%。此外，我们还将测试 D-二聚体在作为日常护理一部分的患者子集中的诊断准确性，以及 将为其他多个辅助目标收集数据。该项目还将确定哪些因素真正增加 或降低那些对PE产生怀疑的儿童发生PE的可能性，并可能提供更多 医生需要证据依据才能有理性的依据开展体育检查，并提供 不需要电离辐射排除PE的临床标准。

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.