Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— SPES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635257
• Other study ID #: 080974
• Status: Completed
• Phase: N/A
• First received: July 1, 2012
• Last updated: March 14, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

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