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Lung Ultrasound in Pleuritic Chest Pain (UPP)

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ClinicalTrials.gov Identifier: NCT02107001
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Fabiano Di Marco, University of Milan

Brief Summary:
Chest pain is an alarming symptom and one of the most frequent causes of access to the Emergency Departement. Although chest X-ray remains an essential step in the diagnostic process, several studies showed numerous limitations of radiography which frequently is inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of ultrasound, the utilization of ultrasound in the study of the lung has only recently been introduced in the clinical practice. Several studies proved that lung ultrasound is useful in the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is not routinely used in the presence of chest pain. Our hypothesis based on clinical experience is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better than radiography. The primary aim of this study is to verify, in patients affected by pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.

Condition or disease Intervention/treatment
Community Acquired Pneumonia Pleuritis Pulmonary Embolism Lung Cancer Procedure: Lung ultrasound

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Ultrasound in Pleuritic Chest Pain: a Multicenter, Prospective, Diagnostic Accuracy Study.
Study Start Date : March 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with pleuritic chest pain
Study investigators will perform lung ultrasound in each patient with pleuritic chest pain at inclusion
Procedure: Lung ultrasound
Lung ultrasonography performed and interpreted by a physician (Pulmonologist or Emergency Physician) possessing specific knowledge in the procedure and a training of at least 100 thoracic ultrasonographies in accordance to a prespecified protocol.
Other Name: Lung sonography




Primary Outcome Measures :
  1. Sensitivity and specificity of lung ultrasound in pneumonia, chest wall pain, lung cancer, pulmonary embolism or other causes in patients presenting with pleuritic chest pain. [ Time Frame: 30 days ]
    Sensitivity and specificity, positive and negative predictive values of lung ultrasound in pneumonia, chest wall pain, lung cancer, pulmonary embolism or other causes in patients presenting with pleuritic chest pain.


Secondary Outcome Measures :
  1. Accuracy of ultrasound in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction or tumors [ Time Frame: 30 days ]
    Accuracy of ultrasound in differentiating consolidation in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction, tumors or other diseases with respect to the final diagnosis stated by a scientific committee.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inpatients and outpatients presenting with pleuritic chest pain referred for medical consultation to italian university and clinical hospitals.
Criteria

Inclusion Criteria:

  • patient aged 18 years and older
  • patient affected by thoracic pleuritic pain

Exclusion Criteria:

  • patient affected by a chronic condition causing thoracic pain
  • patient affected by acute cardiovascular diseases (e.g. acute coronary syndrome)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107001


Locations
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Italy
Emergency Department, Azienda Ospedaliera Universitaria Careggi, Firenze.
Florence, Italy
USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
Lodi, Italy
- U.O.C Broncopneumologia, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano.
Milan, Italy
Emergency Department, San Paolo Hospital
Milan, Italy
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
Milan, Italy
S.O.C. Pneumologia, Ospedale S. Luca, Rovigo.
Rovigo, Italy
- Dipartimento di Medicina d'Urgenza, Ospedale Universitario, S. Luigi Gonzaga, Orbassano (TO).
Turin, Italy
Sponsors and Collaborators
University of Milan
Investigators
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Principal Investigator: Giuseppe Francesco Sferrazza Papa, M.D. Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Study Chair: Stefano Centanni, M.D, Ph.D. Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Study Director: Giovanni Volpicelli, M.D. Emergency Medicine staff Physician San Luigi Gonzaga University Hospital Torino, Italy.

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Responsible Party: Fabiano Di Marco, M.D., Ph.D., University of Milan
ClinicalTrials.gov Identifier: NCT02107001    
Other Study ID Numbers: UPP08032014
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Fabiano Di Marco, University of Milan:
Lung ultrasound
Community acquired p neumonia (CAP)
Pleuritis
Pulmonary embolism
Lung Cancer
Additional relevant MeSH terms:
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Pneumonia
Pulmonary Embolism
Pleurisy
Embolism
Chest Pain
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pleural Diseases