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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Volpicelli, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:
NCT01572584
First received: April 4, 2012
Last updated: December 18, 2013
Last verified: December 2013

April 4, 2012
December 18, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01572584 on ClinicalTrials.gov Archive Site
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Lung Ultrasound in the Evaluation of Pneumothorax Size
Accuracy of Lung Ultrasound in the Prediction of Pneumothorax Volume Assessed by CT Scan

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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

Pneumothorax
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
16 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01572584
SLG-181/2011
No
Giovanni Volpicelli, San Luigi Gonzaga Hospital
San Luigi Gonzaga Hospital
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Principal Investigator: Giovanni Volpicelli, MD San Luigi Gonzaga Hospital
San Luigi Gonzaga Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP