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临床试验/NCT03181152
NCT03181152招募中不适用

The Application of Impulse Oscillometry on the Differential Diagnosis of ACOS,Asthma and COPD.

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Primary Data:physiological graph of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group

研究概览

简要总结

To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients with ACOS,asthma and COPD over Age 40.

详细描述

ACOS,asthma and COPD are prevalent diseases with similar manifestations and different type airway impairments. The differential diagnosis is not easy because the patients always complain of the similar symptoms and are not able to complete spirometry well.

Impulse Oscillometry System (IOS) is capable of identifying airway obstruction and reactions to bronchodilators by providing impedance data and curves. IOS is also a patient-friendly and valuable tool with minimal demands on patient and requiring only passive cooperation.

IOS is a tool to measure lung function during tidal breathing. The output is a measure of respiratory impedance (Zrs), which include the respiratory resistance (Rrs) and respiratory reactance (Xrs) measured over a range of frequencies (usually from 3 to 35 Hz).

The main objective of this study is to investigate the ability of IOS to measure small airway disease by providing different impedance profiles for participants with ACOS,asthma and COPD. Another objective of this study is to investigate the differential ability to identify three diseases by measuring airway impedance and reactions to bronchodilators.

First,participants completed the IOS test.Second,participants inhaled salbutamol for 200g 15 minutes to repeat the IOS.The investigators collect these 2 data for analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 1.1 ACOS:
  • Patient is older than 40 years old.
  • There are characteristics of bronchial asthma and COPD.
  • There is a history of exposure to risk factors.
  • Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC<0.7, and lung function proved reversible exhalation.
  • The existence of reversible airflow limitation: Bronchial Dilation Test positive.
  • 1.2Asthma: 1)Patient is older than 40 years old. 2)History of reversible respiratory symptoms. 3) non-smokers. 4)lung function:At least one time proved that the airflow limitation: Bronchial Dilation Test positive.
  • previously diagnosed asthma. 1.3COPD:
  • Patient is older than 40 years old.
  • Complaints about dyspnea, chronic cough or expectoration.
  • There is a history of exposure to risk factors.
  • Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC<0.
  • The existence of irreversible airflow limitation: Bronchial Dilation Test negative.

排除标准

  • 2.1 Combining other respiratory diseases that affect airflow,such as lung cancer, tuberculosis, pneumonia and bronchiectasis.
  • 2.2 At the time doing lung function test, the factors that affect the airflow limitation are not stopped or just stopped with the time interval not long enough to meet the test standard.
  • 2.3 Using special accompanying medication. For example, patients with drugs such as glucocorticoid.

结局指标

主要结局

Primary Data:physiological graph of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group

时间窗: 2018-8-30

Graph(IOS combing BDT):Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.

Primary Data:physiological parameter of IOS in ACOS/Asthma/COPD group

时间窗: 2018-8-30

Parameter : parameter about respiratory impedance (Zrs): Z5,Zrs; parameter about respiratory resistance (Rrs):R5,R20,R10,R35,R5%,R20%,R10%;R35%,△R5-R20,△R10-R20,△R5-R10; parameter about respiratory reactance (Xrs): X5,X20,X35, other parameter: fres,△AX, Alx,

Primary Data:physiological graph of IOS in ACOS/Asthma/COPD group

时间窗: 2018-8-30

Graph:Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.

Primary Data:physiological parameter of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group

时间窗: 2018-8-30

Parameter (IOS combing BDT): parameter about respiratory impedance (Zrs): Z5,Zrs; parameter about respiratory resistance (Rrs):R5,R20,R10,R35,R5%,R20%,R10%;R35%,△R5-R20,△R10-R20,△R5-R10; parameter about respiratory reactance (Xrs): X5,X20,X35, other parameter: fres,△AX, Alx,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YIZHUO GAO

master

Shengjing Hospital

研究点 (1)

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