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Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism (SPES)
Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study
Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.
Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Forlì, Italië, 47121
- Department of Emergency Medicine, Pierantoni Morgagni Hospital
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Torino, Italië, 10043
- Department of Emergency Medicine, San Luigi Gonzaga University Hospital
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Tuscany
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Firenze, Tuscany, Italië, 50134
- Emergency Department Azienda Ospedaliera Universitaria Careggi
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients with clinical suspected pulmonary embolism
- Simplified Well's score>4 (PE likely) or D-dimer value ≥500ng/ml
- Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism
Exclusion Criteria:
- Refused consent
- Less than 18 years old
- Not possible to perform ultrasound scan within 3 hours before MCTPA
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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suspected pulmonary embolism patients
patients with clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml presenting to the emergency departments of Careggi University Hospital (Firenze), of San Luigi Gonzaga University Hospital (Torino) of Ospedale Pierantoni-Morgagni (Forlì)
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A multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA.
Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Accuracy of ultrasound for the diagnosis of pulmonary embolism
Tijdsspanne: The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.
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Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of limb, cardiac, thoracic and multi-organ ultrasound for the diagnosis of pulmonary embolism in the emergency department considering as gold standard the Multidetector Computed Tomography Angiography (MCTPA)
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The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Stefano Grifoni, MD, Director of Pronto Soccorso generale of AUO Careggi
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 080974
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