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

October 21, 2014 updated by: Paula Morisco de Sá, Rio de Janeiro State University

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de janeiro, Brazil, 21550-013
        • Laboratório de Instrumentação Biomédica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • • Volunteers with silicosis for Patients Group;

    • Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

  • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Control group
Group of nonsmokers individuals without respiratory disease.
normal exam
subjects with silicosis , but with normal spirometric data
mild obstruction
subjects with silicosis with mild obstruction in spirometric data
moderate to severe obstruction
subjects with silicosis with moderate to severe obstruction in spirometric data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spirometric
Time Frame: 1 day
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
Forced Oscillation technique
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silicose2012 (Other Identifier: UERJ)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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