Clinical trial NCT02107001: Lung Ultrasound in Pleuritic Chest Pain
Official title: Lung Ultrasound in Pleuritic Chest Pain: a Multicenter, Prospective, Diagnostic Accuracy Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Pleuritis
Pulmonary Embolism
Lung Cancer
Keywords: Lung ultrasound
Community acquired p neumonia (CAP)
Pleuritis
Pulmonary embolism
Lung Cancer
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients and outpatients presenting with pleuritic chest pain referred for medical consultation to italian university and clinical hospitals.

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: Accuracy of ultrasound in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction or tumors
timeFrame: 30 days
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Emergency Department, Azienda Ospedaliera Universitaria Careggi, Firenze.
city: Lodi
country: Italy
facility: USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
city: Milan
country: Italy
facility: - U.O.C Broncopneumologia, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano.
city: Milan
country: Italy
facility: Emergency Department, San Paolo Hospital
city: Milan
country: Italy
facility: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
city: Rovigo
country: Italy
facility: S.O.C. Pneumologia, Ospedale S. Luca, Rovigo.
city: Turin
country: Italy
facility: - Dipartimento di Medicina d'Urgenza, Ospedale Universitario, S. Luigi Gonzaga, Orbassano (TO).
Study officials:
affiliation: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
name: Giuseppe Francesco Sferrazza Papa, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
name: Stefano Centanni, M.D, Ph.D.
role: STUDY_CHAIR
affiliation: Emergency Medicine staff Physician San Luigi Gonzaga University Hospital Torino, Italy.
name: Giovanni Volpicelli, M.D.
role: STUDY_DIRECTOR
References: