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临床试验/NCT07185581
NCT07185581已完成不适用

Evaluation of Small Airway Function During COPD Exacerbation and Recovery Using Impulse Oscillometry (IOS) Device

Deniz Bilici1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Physiological parameter of IOS in COPD exacerbation period

研究概览

简要总结

This study aimed to evaluate small airway function during ECOPD and recovery periods using IOS. In this prospective single-center study, patients with ECOPD underwent evaluation of their pulmonary functions using IOS and spirometry during exacerbation and recovery (6-12 weeks after exacerbation). The patients were divided into two groups: mild exacerbations and (moderate and severe) exacerbations based on ROME criteria.A total of 41 patients were initially enrolled, with 38 completing the study. This study reveals that IOS can be easily used in ECOPD, and IOS parameters that reflect small airways (R5-R20, AX, and Fres) are correlated with FEV1% and the severity of dyspnea. Additionally, IOS parameters significantly improve during recovery, except for R20. Further research is necessary on its application in the functional assessment of patients with COPD exacerbations.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report

排除标准

  • Patients diagnosed with pneumonia, pulmonary embolism, heart failure, pleural effusion, or pneumothorax were excluded.
  • Patients who were unable to perform spirometry during exacerbation or had a forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of ≥ 0.70 were also excluded.

结局指标

主要结局

Physiological parameter of IOS in COPD exacerbation period

时间窗: from baseline

We investigated descriptive parameters of impulse oscillometry during copd exacerbation period to use in clinical setting in the future. The parameters for assessing airway resistance, including resistance at 5 Hz (R5), which indicates total airway resistance; resistance at 20 Hz (R20), representing the resistance of large airways; and the difference between resistance at 5 Hz and 20 Hz ( R5-R20 ). The parameters that assess reactance are X5, which measures peripheral elastic resistance at 5 Hz; AX, the area under the reactance curve between 5 Hz and the resonant frequency, reflecting the elastic properties of the lung; and Fres, the oscillation frequency at which reactance is zero. In the exacerbation of copd period FEV1% was correlated with all IOS parameters except R20, and BORG was correlated with IOS parameters except R20 and X5. Furthermore, IOS parameters reflecting the small airways (R5-R20, X5, AX, Fres) also showed strong intercorrelations.

次要结局

  • Comparison of parameter of IOS in COPD exacerbation period to stable period (approximately 6 weeks later)(6 weeks later from the baseline)
  • Comparison and correlations of IOS and pulmonary function test parameters in recovery period of COPD patient(6 weeks later from the baseline)

研究者

发起方
Deniz Bilici
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deniz Bilici

md

Istanbul Medeniyet University

研究点 (1)

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