Lung Ultrasound in the Evaluation of Pneumothorax Size

NCT01572584 | Completed

• 1 other identifier: SLG-181/2011
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax

Keywords

Pneumothorax; Lung ultrasound; Chest sonography

Outcome Measures

Primary Outcomes (1)

• The ultrasound lung point on the thorax wall versus the volume of pneumothorax at CT scan

  The ultrasound lung point that the best discriminates a pneumothorax volume more than 11%

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• age less than 16 years

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

San Luigi Gonzaga University Hospital

Orbassano, Torino, 10043, Italy

Location

Related Publications (7)

• 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. doi: 10.1197/j.aem.2005.05.005.

  PMID: 16141018 BACKGROUND

• 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. doi: 10.1378/chest.07-1595. Epub 2007 Oct 9.

  PMID: 17925411 BACKGROUND

• 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. doi: 10.1016/j.ejrad.2004.04.014.

  PMID: 15741021 BACKGROUND

• Lichtenstein D, Meziere G, Biderman P, Gepner A. The "lung point": an ultrasound sign specific to pneumothorax. Intensive Care Med. 2000 Oct;26(10):1434-40. doi: 10.1007/s001340000627.

  PMID: 11126253 BACKGROUND

• 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. doi: 10.1378/chest.119.2.590.

  PMID: 11171742 BACKGROUND

• 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. doi: 10.1378/chest.103.1.26.

  PMID: 8417891 BACKGROUND

• 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.

  PMID: 22392031 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Giovanni Volpicelli, MD

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Department of Emergency Medicine

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

IT (1)