Lung Ultrasound in Pleuritic Chest Pain (UPP)

Lung Ultrasound in Pleuritic Chest Pain: a Multicenter, Prospective, Diagnostic Accuracy Study.

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Community Acquired Pneumonia; Pulmonary Embolism; Pleuritis
• Intervention / Treatment: Procedure: Lung ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy
    • Emergency Department, Azienda Ospedaliera Universitaria Careggi, Firenze.
  • Lodi, Italy
    • USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
  • Milan, 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.
  • Rovigo, Italy
    • S.O.C. Pneumologia, Ospedale S. Luca, Rovigo.
  • Turin, Italy
    • - Dipartimento di Medicina d'Urgenza, Ospedale Universitario, S. Luigi Gonzaga, Orbassano (TO).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatients and outpatients presenting with pleuritic chest pain referred for medical consultation to italian university and clinical hospitals.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Lung sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of ultrasound in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction or tumors	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.	30 days

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (ESTIMATE): April 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Lung Cancer; Lung ultrasound; Pulmonary embolism; Community acquired p neumonia (CAP); Pleuritis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pain; Neurologic Manifestations; Pleural Diseases; Embolism and Thrombosis; Embolism; Chest Pain; Pulmonary Embolism; Pleurisy
• Other Study ID Numbers: UPP08032014