Pulmonary Embolism Clinical Trial
— SPESOfficial title:
Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study
Verified date | March 2013 |
Source | Azienda Ospedaliero-Universitaria Careggi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 357 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Emergency Department Azienda Ospedaliera Universitaria Careggi | Firenze | Tuscany |
Italy | Department of Emergency Medicine, Pierantoni Morgagni Hospital | Forlì | |
Italy | Department of Emergency Medicine, San Luigi Gonzaga University Hospital | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Careggi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of ultrasound for the diagnosis of pulmonary embolism | 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) | 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. | No |
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