An observational study in Silicosis, sponsored by Rio de Janeiro State University. Completed at 1 site in Brazil. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-23.
Sponsored by Rio de Janeiro State University · Observational
Silicosis is a chronic and incurable occupational disease that can progress independent of the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may help to improve our understanding of the changes in lung mechanics, as well as in the detection of these changes.
Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory impedance and evaluated the diagnostic use of the FOT in these patients. For this, the investigators used spirometry to classify airway obstruction, which resulted in four categories: control, patients with normal exam, mild obstruction, and moderate-to-severe obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic potential was evaluated by investigating the area under the receiver operating characteristic curve (AUC).
20 studies on the registry are indexed under Silicosis; 3 are open to participants now.
This study's enrollment of 67 is below the median of 150 across 11 observational studies indexed under Silicosis.
Browse Silicosis studies →Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations.
The group with diagnosis of silicosis was established based on a history of substantial exposure to silica dusts and compatible radiological features, together with exclusion of other competing diagnoses.
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Volunteers with silicosis for Patients Group;
Exclusion Criteria:
Group of nonsmokers individuals without respiratory disease.
subjects with silicosis , but with normal spirometric data
subjects with silicosis with mild obstruction in spirometric data
subjects with silicosis with moderate to severe obstruction in spirometric data
spirometric
Spirometry was used to classify airway obstruction, which resulted in four categories: control (n=21), patients with normal exam (n=12), mild obstruction (n=22), and moderate-to-severe obstruction (n=12).
Time frame: 1 day
Forced Oscillation technique
In the analysis of the forced oscillation technique was used the following data: Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The researchers also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz).
Time frame: 1 day
The record gives a start of Jul 2010, a primary completion of Dec 2012 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Rio de Janeiro State University