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
  Purpose

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.


Condition Intervention
Pulmonary Embolism
Other: Ultrasound scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero-Universitaria Careggi:

Primary Outcome Measures:
  • 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)


Enrollment: 357
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01635257

Locations
Italy
Emergency Department Azienda Ospedaliera Universitaria Careggi
Firenze, Tuscany, Italy, 50134
Department of Emergency Medicine, Pierantoni Morgagni Hospital
Forlì, Italy, 47121
Department of Emergency Medicine, San Luigi Gonzaga University Hospital
Torino, Italy, 10043
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
Study Chair: Stefano Grifoni, MD Director of Pronto Soccorso generale of AUO Careggi
  More Information

No publications provided by Azienda Ospedaliero-Universitaria Careggi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peiman Nazerian, Medical Doctor Emergency Medicine, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT01635257     History of Changes
Other Study ID Numbers: 080974
Study First Received: July 1, 2012
Last Updated: March 14, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero-Universitaria Careggi:
pulmonary embolism diagnosis
ultrasound

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014