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

NCT ID: NCT01725971

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-06-30

Brief 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).

Conditions

Silicosis

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control group

Group of nonsmokers individuals without respiratory disease.

No interventions assigned to this group

normal exam

subjects with silicosis , but with normal spirometric data

No interventions assigned to this group

mild obstruction

subjects with silicosis with mild obstruction in spirometric data

No interventions assigned to this group

moderate to severe obstruction

subjects with silicosis with moderate to severe obstruction in spirometric data

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• • Volunteers with silicosis for Patients Group;

• Volunteers without any respiratory disease for the control group.

Exclusion Criteria

• Smokers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Paula Morisco de Sá

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratório de Instrumentação Biomédica

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Sa PM, Lopes AJ, Jansen JM, Melo PL. Oscillation mechanics of the respiratory system in never-smoking patients with silicosis: pathophysiological study and evaluation of diagnostic accuracy. Clinics (Sao Paulo). 2013 May;68(5):644-51. doi: 10.6061/clinics/2013(05)11.

Reference Type: DERIVED

PMID: 23778400 (View on PubMed)

Other Identifiers

Silicose2012

Identifier Type: OTHER

Identifier Source: secondary_id

Silicose2012

Identifier Type: -

Identifier Source: org_study_id