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Lung Ultrasound in the Evaluation of Pneumothorax Size (LUS-PNXsize)

This study is currently recruiting participants.
Verified December 2012 by San Luigi Gonzaga Hospital
Sponsor:
Information provided by (Responsible Party):
Giovanni Volpicelli, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:
NCT01572584
First received: April 4, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

Background

  • Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax.
  • The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate.
  • Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.
  • The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax []. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume.

Aim

  • Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax.
  • The main hypothesis of the study is that the cut-off between small (<11% of lung collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax.
  • Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT.
  • Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse.

Methods

  • Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and submitted to lung ultrasound within 20 min from the CT study.
  • Different locations of the sonographic "lung point" on the chest wall (i.e. the point on the chest wall where the sonographic pattern of the normally aerated lung alternates with the pathologic sonographic pattern of pneumothorax) are compared with different volumes of pneumothorax measured by CT.

Condition
Pneumothorax

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Lung Ultrasound in the Prediction of Pneumothorax Volume Assessed by CT Scan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Luigi Gonzaga Hospital:

Primary Outcome Measures:
  • The ultrasound lung point on the thorax wall versus the volume of pneumothorax at CT scan [ Time Frame: The ultrasound lung point that the best discriminates a pneumothorax volume more than 11% ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from the Emergency Department Patients admitted to the Hospital Outpatients from the Radiology Department who undergo invasive thoracic procedures

Criteria

Inclusion Criteria:

  • Radiologic diagnosis of pneumothorax
  • Clinical need to perform a CT scan
  • Ability to perform the lung ultrasound imaging within 20 minutes from the CT study

Exclusion Criteria:

  • age less than 16 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572584

Contacts
Contact: Giovanni Volpicelli, MD +39 330 368347 gio.volpicelli@tin.it
Contact: Mauro Frascisco, MD +39 335 7274699 mauro.cisco@gmail.com

Locations
Italy
San Luigi Gonzaga University Hospital Recruiting
Orbassano, Torino, Italy, 10043
Contact: Giovanni Volpicelli, MD     +39 330 368347     gio.volpicelli@tin.it    
Contact: Mauro Frascisco, MD     +39 335 7274699     mauro.cisco@gmail.com    
Principal Investigator: Giovanni Volpicelli, MD            
Sub-Investigator: Enrico Boero, MD            
Sub-Investigator: Alessandro Lamorte, MD            
Sub-Investigator: Mattia Tullio, MD            
Sub-Investigator: Luciano Cardinale, MD            
Sub-Investigator: Marco Busso, MD            
Sub-Investigator: Francesco Boccuzzi, MD            
Sponsors and Collaborators
San Luigi Gonzaga Hospital
Investigators
Principal Investigator: Giovanni Volpicelli, MD San Luigi Gonzaga Hospital
  More Information

Publications:

Responsible Party: Giovanni Volpicelli, Medical Doctor, Department of Emergency Medicine, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT01572584     History of Changes
Other Study ID Numbers: SLG-181/2011
Study First Received: April 4, 2012
Last Updated: December 13, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by San Luigi Gonzaga Hospital:
Pneumothorax
Lung ultrasound
Chest sonography

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013