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

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ClinicalTrials.gov Identifier: NCT01572584

Recruitment Status : Completed

First Posted : April 6, 2012

Last Update Posted : December 19, 2013

Sponsor:

Information provided by (Responsible Party):

Giovanni Volpicelli, San Luigi Gonzaga Hospital

Study Description

Brief Summary:

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 or disease
Pneumothorax

Study Design


Study Type :	Observational
Actual Enrollment :	115 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Accuracy of Lung Ultrasound in the Prediction of Pneumothorax Volume Assessed by CT Scan
Study Start Date :	December 2011
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Primary spontaneous pneumothorax

MedlinePlus related topics: Collapsed Lung Ultrasound

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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% ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 90 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572584

Locations


Italy
San Luigi Gonzaga University Hospital
Orbassano, Torino, Italy, 10043

Sponsors and Collaborators

San Luigi Gonzaga Hospital

Investigators


Principal Investigator:	Giovanni Volpicelli, MD	San Luigi Gonzaga Hospital

More Information

Publications:

Blaivas M, Lyon M, Duggal S. A prospective comparison of supine chest radiography and bedside ultrasound for the diagnosis of traumatic pneumothorax. Acad Emerg Med. 2005 Sep;12(9):844-9.

Soldati G, Testa A, Sher S, Pignataro G, La Sala M, Silveri NG. Occult traumatic pneumothorax: diagnostic accuracy of lung ultrasonography in the emergency department. Chest. 2008 Jan;133(1):204-11. Epub 2007 Oct 9.

Reissig A, Kroegel C. Accuracy of transthoracic sonography in excluding post-interventional pneumothorax and hydropneumothorax. Comparison to chest radiography. Eur J Radiol. 2005 Mar;53(3):463-70.

Lichtenstein D, Mezière G, Biderman P, Gepner A. The "lung point": an ultrasound sign specific to pneumothorax. Intensive Care Med. 2000 Oct;26(10):1434-40.

Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. Review.

Engdahl O, Toft T, Boe J. Chest radiograph--a poor method for determining the size of a pneumothorax. Chest. 1993 Jan;103(1):26-9.

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Review.


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
First Posted:	April 6, 2012 Key Record Dates
Last Update Posted:	December 19, 2013
Last Verified:	December 2013

Keywords provided by Giovanni Volpicelli, San Luigi Gonzaga Hospital:


Pneumothorax Lung ultrasound Chest sonography

Additional relevant MeSH terms:


Pneumothorax Pleural Diseases Respiratory Tract Diseases

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