Pulmonary Embolism Diagnosis: Ultrasound Wells Score vs Traditional Wells Score

NCT02190110 | Completed

• 1 other identifier: 1001
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism; diagnosis; emergency medicine; ultrasonography

Outcome Measures

Primary Outcomes (1)

• ultrasound Wells score vs traditional Wells score diagnostic performance.

  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.

  2 weeks after the end of recruitment

Secondary Outcomes (1)

• Failure rate and efficiency of traditional and US Wells

  2 weeks after the end of recruitment

Study Arms (1)

Suspected pulmonary embolism patients

Adult patients (more than 18 years old) suspected of PE will be recruited at the time of the medical evaluation and before a final diagnosis is established

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (more than 18 years old) suspected of PE presenting to ED will be recruited at the time of the medical evaluation and before a final diagnosis is established.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (4)

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Ospedale San Paolo, Università degli studi di Milano

Milan, Italy

Location

Department of Internal Medicine, Università degli studi di Perugia

Perugia, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Torino, Italy

Location

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peiman Nazerian, MD

  Azienda Ospedaliera Universitaria Careggi, Firenze, Italia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Emergency Medicine

Study Record Dates

• First Submitted: July 12, 2014
• First Posted: July 15, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

IT (4)