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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobika with hypertonic saline nebulization | Experimental | Inhalation involves breathing through the device Aerobika with the dedicated AeroEclipse XL BAN nebulizer. The level of expiratory resistance is adjusted individually. The pressure ranges from 5 to 20 cm H2O, and the oscillation frequency is approximately 15 Hz. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day. |
|
| PEP with hypertonic saline nebulization | Experimental | Inhalation using the PARI PEP® S System involves breathing through the device with the dedicated Pari LC Sprint nebulizer. The level of expiratory resistance is adjusted individually. The pressure in the mid-expiratory range is 10-20 cmH2O. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day. |
|
| hypertonic saline nebulization control group | Experimental | Inhalation with a hypertonic saline solution using a Pari LC Sprint nebulizer with a mouthpiece and nasal clip. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulization with OPEP device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Pulmonary Function Test (PFT) | Measured indicators: Bodyplethysmographie: FEV1, FVC, volume measurement (L). Change from baseline during hospitalization (at least 8 days). | From baseline to study completion, the average duration is 10 days. |
| 1. Pulmonary Function Test (PFT) | Measured indicators: Bodyplethysmographie: MEF 50, flow measurement (l/s). Change from baseline during hospitalization (at least 8 days). | From baseline to study completion, the average duration is 10 days. |
| 1.2 Pulmonary Function Test (PFT) | Measured indicators: Impulse Oscillometry, IOS: R20, R5 kilopaskal per litre per second (kPa/l/s). Change from baseline during hospitalization (at least 8 days). | From baseline to study completion, the average duration is 10 days. |
| Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R) | 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. | From baseline to study completion, the average duration is 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sputum expectorated. | Volume measurement [ml], during inhalation and during physiotherapy. | From baseline to study completion, the average duration is 10 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Warzeszak | National Tuberculosis and Lung Diseases Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Tuberculosis and Lung Diseases Research Institute | Rabka-Zdrój | Malopolska | 34-700 | Poland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19648517 | Background | Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208. | |
| 32026826 | Background | San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
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|
| Nebulization with PEP device | 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. |
|
| Nebulization with Pari LC Sprint | 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. |
|
| National Institute Tuberculosis and Lung Diesases |
| Rabka-Zdrój |
| Małopolska |
| 34-700 |
| Poland |
| 26003070 | Background | Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9. |
| 23920213 | Background | Berlinski A. In vitro evaluation of positive expiratory pressure devices attached to nebulizers. Respir Care. 2014 Feb;59(2):216-22. doi: 10.4187/respcare.02698. Epub 2013 Aug 6. |
| 15065835 | Background | Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |