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Pulmonary Embolism Diagnosis: Ultrasound Wells Score vs Traditional Wells Score

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02190110
Enrollment
444
Registered
2014-07-15
Start date
2014-08-31
Completion date
2015-07-31
Last updated
2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism, diagnosis, emergency medicine, ultrasonography

Brief summary

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.

Interventions

None listed

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
ultrasound Wells score vs traditional Wells score diagnostic performance.2 weeks after the end of recruitmentThe diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios.

Secondary

MeasureTime frameDescription
Failure rate and efficiency of traditional and US Wells2 weeks after the end of recruitmentFailure rate and efficacy of d-dimer in patients stratified as PE likely and PE unlikely will also be calculated. Failure rate (false negative proportion) will be calculated as the number of patients with negative d-dimer and confirmed PE diagnosis, divided for all patients with negative d-dimer in the same risk group. The efficiency will be calculated as the number of patients with negative d-dimer in one risk group divided for all patients included in the study.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026