Cystic Fibrosis
Conditions
Keywords
Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage
Brief summary
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).
Detailed description
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
Interventions
DEVICEINHALATION WITH PEP DEVICE (Acapella Duet)
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
Sponsors
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
* Pass the inhalation test * Chronic sputum production, at least ≥ 10 ml /24h * Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l) * Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks) * Trained in the use of autogenic drainage technique (at least 6 months) * Inhaling hypertonic saline since at least 6 months * To be able to provide written, informed consent and perform the protocol and the evaluations
Exclusion criteria
* Active massive hemoptysis during the previous 2 months * Patient in transplantation or retransplantation list * Patient already participating in another study at the same time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum production | 45 minutes | Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate) | 45 minutes | Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate |
| Patient's perception (Likert test) | 5 days | Likert test |
| Wet sputum production | 2 hours | 2 hours wet sputum production (ml) after chest physiotherapy session |
| Lung function (simply spirometry) | 5 days | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 |
| Questionnaire | 5 days | Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S) |
Countries
Spain
Outcome results
None listed