UPP: Lung Ultrasound in Pleuritic Chest Pain

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT02107001
Collaborator
(none)
400
7
20
57.1
2.9

Study Details

Study Description

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 Phase
  • Procedure: Lung ultrasound

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm 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 Names:
  • Lung sonography
  • Outcome Measures

    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. [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency Department, Azienda Ospedaliera Universitaria Careggi, Firenze. Florence Italy
    2 USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi Lodi Italy
    3 - U.O.C Broncopneumologia, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano. Milan Italy
    4 Emergency Department, San Paolo Hospital Milan Italy
    5 Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano. Milan Italy
    6 S.O.C. Pneumologia, Ospedale S. Luca, Rovigo. Rovigo Italy
    7 - Dipartimento di Medicina d'Urgenza, Ospedale Universitario, S. Luigi Gonzaga, Orbassano (TO). Turin Italy

    Sponsors and Collaborators

    • University of Milan

    Investigators

    • 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fabiano Di Marco, M.D., Ph.D., University of Milan
    ClinicalTrials.gov Identifier:
    NCT02107001
    Other Study ID Numbers:
    • UPP08032014
    First Posted:
    Apr 8, 2014
    Last Update Posted:
    Dec 2, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Fabiano Di Marco, M.D., Ph.D., University of Milan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2015