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| ID | Type | Description | Link |
|---|---|---|---|
| 239|2012 | Other Grant/Funding Number | SEPAR |
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This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USUAL CARE | No Intervention | Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. | |
| INHALATION WITH PEP DEVICE | Active Comparator | Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INHALATION WITH PEP DEVICE (Acapella Duet) | Device | Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage) | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | 2 hours wet sputum production (ml) after chest physiotherapy session | 2 hours |
| Wet sputum production | 22 hours wet sputum production (ml) after chest physiotherapy session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta San Miguel | Universidad San Jorge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Aragonesa de Fibrosis QuÃstica | Zaragoza | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37319354 | Derived | Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5. | |
| 32026826 | Derived | 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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| 22 hours |
| Lung function (simply spirometry) | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 | 5 days |
| Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate) | Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate | 45 minutes |
| Patient's perception (Likert test) | Likert test | 5 days |
| Questionnaire | Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S) | 5 days |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |