Impact of Continuous Isotonic Saline Nebulisation Combined With Heated Humidification on the Rheology of Bronchial Secretions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate whether adding a continuous mist of saltwater (saline nebulization) to warmed, humidified air can improve the properties of mucus in the lungs compared to humidified air alone.
Some patients with chronic lung diseases produce large amounts of thick mucus, which can be difficult to clear and may worsen breathing. Making this mucus easier to move and remove could help improve comfort and breathing.
In this study, 35 adult patients hospitalized for lung conditions with excessive mucus production will participate. Each patient will receive both treatments on two different days, in a random order:
Heated humidified air alone Heated humidified air combined with continuous saline nebulization This design allows each patient to serve as their own comparison. At the beginning and end of each session, a physiotherapist will help patients clear their airways, and mucus samples will be collected. Each treatment session will last 4 hours.
The collected mucus will be analyzed in a laboratory to measure how thick, sticky, or elastic it is, and how much force is needed to move it. The main goal is to determine whether the combined treatment makes mucus easier to clear.
The study will also assess patient comfort, breathing difficulty, ease of clearing mucus, and sleep quality after treatment.
The results of this study may help improve airway care for patients with chronic lung diseases by identifying more effective ways to manage excessive mucus.
详细描述
Aim- The objective of this study is to determine the effect of continuous isotonic saline nebulization combined with heated humidification on mucus rheology characteristics compared with heated humidification alone.
Design study- This experimental study will follow a cross-over design. As mucus rheology characteristics vary among individuals, this design will enable each subject to be his own control.
Population- 35 patients with excessive airway secretions will be included in this study (sample size calculated with a 95% confidence level and 80% power). Patients will undergo screening for eligibility upon admission to the pulmonology unit. Individuals with chronic pulmonary conditions leading to excessive airway secretions (> 20 mL of expectoration per day) and meeting the inclusion criteria will be invited to participate in the study. The study will take place on two days, after inclusion, randomization will determine the sequence of administration for the two treatments being compared.
Intervention- A continuous isotonic saline nebulization will be delivered combined with a heated humidification.
The continuous nebulization will be performed using the Aerogen continuous nebulization set to assure the continuous supply of isotonic saline solution into the aerogen solo mesh nebulizer.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Hospitalized in pulmonology unit
- •Excessive airways secretions disease: COPD, Bronchiectassies, Cystic Fibrosis, Primary Ciliary Diskynesia
排除标准
- •Age < 18 years old
- •Under invasive or non invasive ventilation
- •>15L/min of oxygen
- •Mucoactive treatment
- •Artificial Upper Airway
- •Respiratory Distress
研究组 & 干预措施
Saline + Humidification
干预措施: Saline Nebulization (Device)
Saline + Humidification
干预措施: Heated humidification (Device)
Humidification
干预措施: Heated humidification (Device)
