Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism (SPES)
|ClinicalTrials.gov Identifier: NCT01635257|
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : March 18, 2013
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.
|Condition or disease||Intervention/treatment|
|Pulmonary Embolism||Other: Ultrasound scan|
|Study Type :||Observational|
|Actual Enrollment :||357 participants|
|Official 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|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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)
Other: Ultrasound scan
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.
- Accuracy of ultrasound for the diagnosis of pulmonary embolism [ Time Frame: 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. ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635257
|Emergency Department Azienda Ospedaliera Universitaria Careggi|
|Firenze, Tuscany, Italy, 50134|
|Department of Emergency Medicine, Pierantoni Morgagni Hospital|
|Forlì, Italy, 47121|
|Department of Emergency Medicine, San Luigi Gonzaga University Hospital|
|Torino, Italy, 10043|
|Study Chair:||Stefano Grifoni, MD||Director of Pronto Soccorso generale of AUO Careggi|