Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism (SPES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT01635257
First received: July 1, 2012
Last updated: March 14, 2013
Last verified: March 2013

July 1, 2012
March 14, 2013
June 2012
December 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01635257 on ClinicalTrials.gov Archive Site
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Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism
Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Pulmonary Embolism
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.
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)
Intervention: Other: Ultrasound scan
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):950-7. doi: 10.1378/chest.13-1087.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01635257
080974
No
Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria Careggi
Not Provided
Study Chair: Stefano Grifoni, MD Director of Pronto Soccorso generale of AUO Careggi
Azienda Ospedaliero-Universitaria Careggi
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP