Lung Ultrasound in Pleuritic Chest Pain

NCT02107001 | Completed

• 1 other identifier: UPP08032014
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 7

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.

Conditions

Community Acquired Pneumonia; Pleuritis; Pulmonary Embolism; Lung Cancer

Keywords

Lung ultrasound; Community acquired p neumonia (CAP); Pleuritis; Pulmonary embolism; Lung Cancer

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Accuracy of ultrasound in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction or tumors

  30 days

Study Arms (1)

Patients with pleuritic chest pain

Study investigators will perform lung ultrasound in each patient with pleuritic chest pain at inclusion

Procedure: Lung ultrasound

Interventions

Lung ultrasound PROCEDURE

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.

Also known as: Lung sonography

Patients with pleuritic chest pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (7)

Emergency Department, Azienda Ospedaliera Universitaria Careggi, Firenze.

Florence, Italy

Location

USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi

Lodi, Italy

Location

- U.O.C Broncopneumologia, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano.

Milan, Italy

Location

Emergency Department, San Paolo Hospital

Milan, Italy

Location

Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.

Milan, Italy

Location

S.O.C. Pneumologia, Ospedale S. Luca, Rovigo.

Rovigo, Italy

Location

- Dipartimento di Medicina d'Urgenza, Ospedale Universitario, S. Luigi Gonzaga, Orbassano (TO).

Turin, Italy

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pleurisy; Pulmonary Embolism; Lung Neoplasms

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Pleural Diseases; Lung Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Giuseppe Francesco Sferrazza Papa, M.D.

  Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.

  PRINCIPAL INVESTIGATOR

• Stefano Centanni, M.D, Ph.D.

  Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.

  STUDY CHAIR

• Giovanni Volpicelli, M.D.

  Emergency Medicine staff Physician San Luigi Gonzaga University Hospital Torino, Italy.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

IT (7)