Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis

Silicosis Clinical Trial

Official title:

The Use of Forced Oscillation Technique in the Analysis of Respiratory System in Never-smoking Patients With Silicosis:Pathophysiological Study and Evaluation of Diagnostic Accuracy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725971
• Other study ID #: Silicose2012
• Secondary ID: Silicose2012
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: October 21, 2014
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• • Volunteers with silicosis for Patients Group;

• Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

• Smokers

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Silicosis

Locations

Country	Name	City	State
Brazil	Laboratório de Instrumentação Biomédica	Rio de janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day	No
Primary	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).	1 day	No