跳至主要内容
临床试验/CTRI/2025/12/098503
CTRI/2025/12/098503尚未招募不适用

Bronchodilator Response of Lung Oscillometry Parameters in Healthy Adults: A Pilot Study

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
The outcome variables will be whole-breath resistance at 5 Hz (R5), whole-breath reactance at 5 Hz (X5), frequency dependence of resistance (R5–20), resonant frequency (Fres), and reactance area (AX), defined as the integral of reactance between 5 Hz and Fres.

研究概览

简要总结

Oscillometry is a simple, non-invasive technique used to assess lung mechanics, particularly for diagnosing small airway dysfunction. Unlike spirometry, oscillometry does not require forceful breathing maneuvers and is increasingly being adopted in clinical practice for the management of obstructive lung diseases. Similar to spirometry, bronchodilator responsivenessof oscillometry is assessed after administering 400 µg of inhaled salbutamol. However, the criteria for defining a bronchodilator response in oscillometry remain unclear and not well established. This study aims to assess changes in oscillometry parameters following bronchodilator administration in a healthy adult population, providing baseline data that may help guide future clinical interpretation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • No prior history of respiratory disease and non smoker.

排除标准

  • Recent respiratory infection (within 4 weeks).
  • Known cardiac disease or uncontrolled systemic illness.
  • iii.No prior history of respiratory disease (asthma, COPD, bronchiectasis, ILD, pulmonary tuberculosis, etc.).
  • Never-smoker.

结局指标

主要结局

The outcome variables will be whole-breath resistance at 5 Hz (R5), whole-breath reactance at 5 Hz (X5), frequency dependence of resistance (R5–20), resonant frequency (Fres), and reactance area (AX), defined as the integral of reactance between 5 Hz and Fres.

时间窗: The outcome variables will be whole-breath resistance at 5 Hz (R5), whole-breath reactance at 5 Hz (X5), frequency dependence of resistance (R5–20), resonant frequency (Fres), and reactance area (AX), defined as the integral of reactance between 5 Hz and Fres.

次要结局

  • To compare the variability of oscillometry parameters across different age groups andbetween genders following administration of inhaled bronchodilator.

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sajal De

All India Institute of Medical Sciences Raaipur

研究点 (1)

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