The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- 1. Pulmonary Function Test (PFT)
研究概览
简要总结
Physiotherapy is an essential element in the comprehensive treatment of patients with cystic fibrosis. In symptomatic individuals, from a respiratory system perspective, it should be performed regularly, as it directly contributes to slowing disease progression. Even though patients perform airway-clearing physical therapy daily, it should be intensified during exacerbations. Although solutions for effectively clearing the airways have been sought for many years, there is still no leading technique for removing secretions from the respiratory tract. Modifications during inhalation aimed at thinning and loosening the accumulated thick mucus can facilitate the effective mobilization and expectoration of secretions, thus improving patients' quality of life.
详细描述
The study aims to determine whether the addition of devices with positive expiratory pressure (Pari PEP System S) or positive pressure with oscillation (Aerobika) assists with hypertonic saline nebulization in patients with cystic fibrosis exacerbation. The study assesses whether these devices facilitate the easier evacuation of retained secretions, shorten bronchial drainage time, and improve pulmonary function test results. Participants are randomly assigned to specific groups (Group I - inhalation with O-PEP, Group II - inhalation with PEP, Group III - control group, standard inhalation) using a calendar formula (day of the month divided by 3). Each group performs bronchial drainage following the same protocol: autogenic drainage and a device with positive variable expiratory pressure (device name: Pari O-PEP).
The main questions the study aims to answer are: 1. Does implementing inhalation devices improve functional test indicators and the amount of mucus expectorated during inhalation? 2. Are there differences in effectiveness between the groups?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent of the patient and/or guardian,
- •no disease complications (within the last 2 months) in the form of: active haemoptysis, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
- •Age above 10 years,
- •the ability to perform correctly lung function tests and FEV1 value above 20% predicted,
- •the presence of respiratory symptoms indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in FEV1 by 10% or more from a previously recorded value.
排除标准
- •Lack of written consent for the study
- •Hemoptysis within the last 2 months
- •History of pneumothorax
- •Current otitis media
- •Age below 10 years
- •FEV1 value below 20% of the predicted value
- •Surgical procedures in the area of the oesophagus (esophageal varices)
- •Intolerance to the PEP or O-PEP device
结局指标
主要结局
1. Pulmonary Function Test (PFT)
时间窗: From baseline to study completion, the average duration is 10 days.
Measured indicators: Bodyplethysmographie: FEV1, FVC, volume measurement (L). Change from baseline during hospitalization (at least 8 days).
1.2 Pulmonary Function Test (PFT)
时间窗: From baseline to study completion, the average duration is 10 days.
Measured indicators: Impulse Oscillometry, IOS: R20, R5 kilopaskal per litre per second (kPa/l/s). Change from baseline during hospitalization (at least 8 days).
Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)
时间窗: From baseline to study completion, the average duration is 10 days.
A survey assessing the quality of life, dedicated to people with cystic fibrosis. The survey includes questions on: physical, vitality, emotion, eat, treatment burden, health perception, social, body, role, weight, respiratory, digestion. The survey is intended for people with cystic fibrosis and their parents from 6 years of age. Interpretion: a score scale scale title: Manual scoring for the Cystic Fibrosis Questionnaire-Revised (CFQ-R), Teen/adult: Minimum values 1 Maximum values 196, Parents: Minimum values 1 Maximum values 157, Child 12 to 13: minumum values 1 maximum values 128, Child 6 to 11: minumum values 1 maximum values 128.
次要结局
未报告次要终点