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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.
During the study period the patients' pharmacological treatment remained unchanged
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autogenic drainage (AD) | Active Comparator | Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations. |
|
| Resistive inspiratory manoeuvre (RIM) | Active Comparator | Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side). |
|
| Resistive inspiratory manoeuvre+autogenic drainage | Active Comparator | First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autogenic drainage (AD) | Other | It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. |
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | 24h wet sputum production (g) after bronchial drainage session | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | Wet sputum production (g) during bronchial drainage session | 30 minutes |
| Computerized respiratory sounds | Adventitous respiratory sounds: crackles and wheezes |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse-oximetry, heart rate and dyspnea | Safety and tolerability of session | 30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz Herrero, Msc | Universidad San Jorge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cystic Fibrosis Association | Madrid | Madrid | Spain | |||
| Cystic Fibrosis Association |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15065835 | Result | 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. |
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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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| Resistive inspiratory manoeuvre (RIM) | Other | It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. |
|
| Resistive inspiratory manoeuvre+autogenic drainage | Other | It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order. |
|
| 30 minutes |
| Lung function (simply spirometry) | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 | 30 minutes |
| Patients´ perception | Visual analogical scale | 30 minutes |
| Murcia |
| Murcia |
| Spain |
| Cystic Fibrosis Association | Valencia | Valencia | Spain |
| Universidad San Jorge | Zaragoza | Zaragoza | 50830 | Spain |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |