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: 10385740
• 负责人: ANGELA M ELLISON
• 金额: $ 169.85万
• 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/10385740
• 关键词: Accident and Emergency department; Adolescent; Adult; Age; Angiography; Applied Research; Autopsy; Caring; Case Fatality Rates; Child; Child Care; Child Health; Chronic Disease; Clinical; Confidence Intervals; Conflict (Psychology); Data; Data Set; Detection; Diagnosis; Diagnostic; Diagnostic Sensitivity; Diagnostic tests; Disease; Emergency Care; Exclusion; Exposure to; Fibrin fragment D; Health Personnel; Heart Rate; Hospitals; Image; Indwelling Catheter; Infection; Injury to Kidney; Intravenous; Ionizing radiation; Lung; Medical; Metabolic syndrome; Methods; Modification; Outcome; Outpatients; Patients; Physicians; Prevalence; Probability; Process; Pulmonary Embolism; Radiation; Radiation exposure; Research; Risk; Safety; Sample Size; Scanning; Sensitivity and Specificity; Signs and Symptoms; Specificity; Suggestion; Symptoms; Techniques; Testing; Work; X-Ray Computed Tomography; aged; associated symptom; base; cancer risk; clinical practice; diagnostic accuracy; evidence base; follow-up; high risk; improved; mortality; novel; older patient; patient subsets; pediatric emergency; prospective; prospective test; pulmonary symptom; treatment as usual

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.

摘要 尚未进行研究来前瞻性记录目前的主诉、体征、症状和 怀疑儿童肺栓塞（PE）的儿童合并症。临床医生必须 将成人的体育知识推广到儿童。这一过程使儿童处于危险之中：大多数 患有PE的儿童在第一次与医疗保健提供者接触后未被诊断，这意味着诊断通常是 耽搁了也许因此，PE的死亡率在儿童中与成人相同。另 另一方面，成千上万的低风险儿童和青少年不必要地暴露在延长的寿命中， 癌症风险来自CT扫描的电离辐射，以寻找他们没有的PE。无临床标准 已经开发出用于估计儿童发生PE的可能性，或根据以下情况排除PE 在床边提供的信息。在成人中，肺栓塞排除标准或PERC规则 已被确认为排除PE的方法。在这项工作中，我们将测试PERC规则的修改，PERC- 儿科，它使用心率的年龄调整，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是否可以安全地排除4，030名5-17岁儿童的PE，这些儿童怀疑 在急诊室里的体育课。标准结局的标准是诊断为PE或DVT， 45天为了达到研究定义的安全性阈值， 排除标准（PERC-Peds）的假阴性率必须低于1.5%。此外，我们将测试 D-二聚体的诊断准确性，在作为常规护理的一部分进行测试的患者亚组中，以及 将为多个其他辅助目的收集数据。该项目还将确定哪些因素真正增加 或降低怀疑PE的儿童发生PE的可能性，并可能提供更多 需要证据基础，以便医生有合理的基础来启动PE检查，并提供 排除PE的临床标准，无需电离辐射。