Cystic Fibrosis
Conditions
Keywords
Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances
Brief summary
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.
Detailed description
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
Interventions
OTHERAutogenic drainage (AD)
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.
OTHERResistive inspiratory manoeuvre (RIM)
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.
OTHERResistive inspiratory manoeuvre+autogenic drainage
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.
Sponsors
Cystic Fibrosis Foundation
Universidad San Jorge
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l) * Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk); * Chronic sputum production, at least ≥ 15 ml /24h * Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions) * To be able to provide written, informed consent
Exclusion criteria
* Lung function: Forced expiratory volume in 1 second \< 30 % pred . ; Forced vital capacity \< 40 % pred. * Active haemoptysis during the previous month * Supplemental oxygen or non-invasive ventilation (NIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum production | 24 hours | 24h wet sputum production (g) after bronchial drainage session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum production | 30 minutes | Wet sputum production (g) during bronchial drainage session |
| Computerized respiratory sounds | 30 minutes | Adventitous respiratory sounds: crackles and wheezes |
| Lung function (simply spirometry) | 30 minutes | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 |
| Patients´ perception | 30 minutes | Visual analogical scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulse-oximetry, heart rate and dyspnea | 30 minutes | Safety and tolerability of session |
Countries
Spain
Outcome results
None listed