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

Completed

• Conditions: Pulmonary Embolism
• Interventions: Other: Ultrasound scan

• Registration Number: NCT01635257
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-01
• Study First Submitted QC: 2012-07-04
• Study First Posted: 2012-07-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
suspected pulmonary embolism patients	Ultrasound scan	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)

Primary Outcome Measures

Name	Time	Method
Accuracy of ultrasound for the diagnosis of pulmonary embolism	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)

Trial Locations

Locations (3)

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, Italy