Lung Ultrasound in the Evaluation of Pneumothorax Size

Completed

• Conditions: Pneumothorax

• Registration Number: NCT01572584
• Lead Sponsor: San Luigi Gonzaga Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

San Luigi Gonzaga University Hospital; 🇮🇹 Orbassano, Torino, Italy