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

NCT01635257 | Completed

• 1 other identifier: 080974
• Study Type: observational
• Target: 357
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism diagnosis; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Ultrasound scan OTHER

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.

suspected pulmonary embolism patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Refused consent
• Less than 18 years old
• Not possible to perform ultrasound scan within 3 hours before MCTPA

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (3)

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Department of Emergency Medicine, Pierantoni Morgagni Hospital

Forlì, 47121, Italy

Location

Department of Emergency Medicine, San Luigi Gonzaga University Hospital

Torino, 10043, Italy

Location

Related Publications (1)

• 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.

  PMID: 24092475 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Stefano Grifoni, MD

  Director of Pronto Soccorso generale of AUO Careggi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Emergency Medicine

Study Record Dates

• First Submitted: July 1, 2012
• First Posted: July 9, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

IT (3)