跳至主要内容
临床试验/NCT02190110
NCT02190110已完成不适用

Ultrasound Wells Score vs Traditional Wells Score in the Diagnostic Approach to Pulmonary Embolism

Azienda Ospedaliero-Universitaria Careggi4 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
444
试验地点
4
主要终点
ultrasound Wells score vs traditional Wells score diagnostic performance.

研究概览

简要总结

Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope, shock/hypotension, or cardiac arrest. Discriminating patients in different categories of pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The most frequently used clinical prediction rule is the Wells score ("PE likely" > 4 points and "PE unlikely" ≤ 4 points). PE can be safely ruled out in patients with a "PE unlikely" associated with a negative d-dimer test result. Conversely, patients with "PE likely" or positive d-dimer level should undergo further diagnostic testing, like multidetector computed tomography pulmonary angiography (MCTPA).

Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as an extension of physical examination and have a high specificity. The aim of this study is to evaluate if the combination of clinical data reported in the Wells score and US data obtained from vein and lung US (US Wells score) has a better diagnostic accuracy compared to traditional Wells score.

In adult patients suspected of PE traditional Wells score will be calculated and vein and lung US (multiorgan US) will be performed in all patients and and US Wells score calculated. The US Wells score differs from the traditional Wells score in the following items: "signs and symptoms of DVT", replaced by "vein US showing DVT", and "alternative diagnosis less likely than PE" replaced by "alternative diagnosis less likely than PE after multiorgan US". This latter item is considered positive if at least one subpleural infarct is detected at lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of presentation. If no findings are detected at lung US, the points for the item remain the same assigned by traditional Wells score. Final diagnosis of PE will be preferentially established by MCTPA and in patients discharged without a second level imaging test because of negative Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter the 3 months follow-up protocol.

The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive, and negative predictive value, and likelihood ratios. Failure rate and efficacy of d-dimer in patients stratified as "PE likely" and "PE unlikely" will also be calculated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients more than 18 years old
  • Patients presenting with dyspnea, thoracic pain or syncope, palpitations, cardiac arrest
  • Suspicion of PE

排除标准

  • Patient did not consent to participate in the study
  • Presence of a diagnosis alternative to PE objectively demonstrated after the first assessment.

结局指标

主要结局

ultrasound Wells score vs traditional Wells score diagnostic performance.

时间窗: 2 weeks after the end of recruitment

The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios.

次要结局

  • Failure rate and efficiency of traditional and US Wells(2 weeks after the end of recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiman Nazerian

Medical Doctor Emergency Medicine

Azienda Ospedaliero-Universitaria Careggi

研究点 (4)

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