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临床试验/NCT01725971
NCT01725971已完成不适用

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

Rio de Janeiro State University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
spirometric

研究概览

简要总结

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).

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Volunteers with silicosis for Patients Group;
  • Volunteers without any respiratory disease for the control group.

排除标准

  • 未提供

结局指标

主要结局

spirometric

时间窗: 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).

Forced Oscillation technique

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Morisco de Sá

researcher

Rio de Janeiro State University

研究点 (1)

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