Lung Ultrasound in Pleuritic Chest Pain

Lung Cancer Clinical Trial

— UPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107001
• Other study ID #: UPP08032014
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: November 30, 2015
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain
• Community Acquired Pneumonia
• Embolism
• Lung Cancer
• Pleuritis
• Pneumonia
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No