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临床试验/NCT07722377
NCT07722377尚未招募不适用

Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Mucociliary clearance

研究概览

简要总结

Mucociliary clearance is an essential defense mechanism of the lungs that helps remove inhaled particles, pathogens, and airway secretions. This process depends on the coordinated action of cilia, mucus properties, and airway hydration. In healthy individuals, mucus is continuously transported toward the throat, allowing effective clearance of harmful substances. However, this mechanism can be influenced by the hydration status of the airway surface liquid.

Heated humidification delivered through high-flow nasal cannula (HFNC) has been shown to improve airway hydration, enhance ciliary function, and support mucociliary clearance. In addition, nebulized saline solutions are commonly used to modify mucus properties. Hypertonic saline has demonstrated short-term benefits in improving mucus hydration and clearance, but its use may be associated with side effects such as airway irritation or bronchoconstriction. In contrast, the effects of isotonic saline remain unclear, particularly when delivered in large volumes.

The rationale of this study is that continuous nebulization of isotonic saline, when combined with heated humidification, may provide a sufficient cumulative amount of sodium to improve airway hydration and mucociliary clearance, potentially mimicking the effects of hypertonic saline without its adverse effects.

This study is a randomized controlled cross-over trial conducted in healthy adult volunteers. Each participant will undergo three experimental sessions: a baseline assessment without intervention, a control condition with heated humidification alone, and an intervention condition combining heated humidification with continuous isotonic saline nebulization. The order of the control and intervention sessions will be randomized.

Mucociliary clearance will be assessed using pulmonary scintigraphy. Participants will inhale radiolabeled aerosol particles (99mTc-DTPA), and the clearance of these particles from the lungs will be monitored over time using a gamma camera. Images will be acquired at regular intervals to quantify the rate of particle retention and clearance under each condition.

The primary objective of the study is to determine whether continuous isotonic saline nebulization combined with heated humidification improves mucociliary clearance compared to heated humidification alone.

Secondary outcomes include the evolution of mucociliary clearance over time during and after the intervention, as well as participant comfort assessed using a Likert scale.

The findings of this study may help improve understanding of airway hydration strategies and contribute to optimizing respiratory care techniques aimed at enhancing mucus clearance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • >18 years old
  • healthy spiromètry

排除标准

  • <18 years old
  • Pathologic spiromètry
  • Active smokers

结局指标

主要结局

Mucociliary clearance

时间窗: 20 minutes interval from the onset through study completion 2 hours

Mucociliary clearance will be assessed using biplane scintigraphy

次要结局

  • Overall Confort during the use of the device(At study completion 2 hours)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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