Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, exacerbations, chest physiotherapy, PEP device, O-PEP device
Brief summary
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.
Detailed description
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?
Interventions
DEVICENebulization with OPEP device
During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: PARI PEP® S System (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the Aerobika\*OPEP Device (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the Pari OPEP device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.
DEVICENebulization with PEP device
During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: PARI PEP® S System (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the Aerobika\*OPEP Device (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the Pari OPEP device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.
DEVICENebulization with Pari LC Sprint
During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: PARI PEP® S System (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the Aerobika\*OPEP Device (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the Pari OPEP device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.
Sponsors
National Institute for Tuberculosis and Lung Diseases, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The physiotherapy program involves: Firstly, performing inhalations with hypertonic saline using one of two devices (Aerobika\*OPEP with AeroEclipse XL BAN nebulizer, PARI PEP® S System with Pari LC Sprint nebulizer). The third group serves as the control group and performs inhalations using the Pari LC Sprint nebulizer. After the inhalation, participants record the amount of sputum expectorated during the inhalation and note the color of the sputum. Secondly, immediately after the hypertonic saline inhalation, participants use physiotherapy focused on airway clearance with the Pari O-PEP Flutter device and perform autogenic drainage for 15 breaths in one cycle. Frequency: twice a day. This cycle is repeated twice. The maximum number of cycles is five, depending on the need. Duration: 15-30 minutes. After the physiotherapy, participants also recorded the amount of expectorated secretion and noted the color of the sputum.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Pulmonary Function Test (PFT) | 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) | 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sputum expectorated. | From baseline to study completion, the average duration is 10 days. | Volume measurement \[ml\], during inhalation and during physiotherapy. |
Countries
Poland
Outcome results
None listed