Clinical trial NCT01635257: Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism diagnosis
ultrasound
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients more than 18 years presenting to three emergency departments with clinical suspected pulmonary embolism. Clinical suspected pulmonary embolism is defined as new onset or worsening dyspnea, chest pain, syncope or shock/Hypotension without an alternative obvious cause

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of ultrasound for the diagnosis of pulmonary embolism
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Emergency Department Azienda Ospedaliera Universitaria Careggi
state: Tuscany
city: Forlì
country: Italy
facility: Department of Emergency Medicine, Pierantoni Morgagni Hospital
city: Torino
country: Italy
facility: Department of Emergency Medicine, San Luigi Gonzaga University Hospital
Study officials:
affiliation: Director of Pronto Soccorso generale of AUO Careggi
name: Stefano Grifoni, MD
role: STUDY_CHAIR
References:
citation: Nazerian P, Vanni S, Volpicelli G, Gigli C, Zanobetti M, Bartolucci M, Ciavattone A, Lamorte A, Veltri A, Fabbri A, Grifoni S. Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism. Chest. 2014 May;145(5):950-957. doi: 10.1378/chest.13-1087.