Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT02261987
- Lead Sponsor
- Universidad San Jorge
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Wet sputum production 24 hours 24h wet sputum production (g) after bronchial drainage session
- Secondary Outcome Measures
Name Time Method 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
Wet sputum production 30 minutes Wet sputum production (g) during bronchial drainage session
Trial Locations
- Locations (2)
Cystic Fibrosis Association
🇪🇸Valencia, Spain
Universidad San Jorge
🇪🇸Zaragoza, Spain
Cystic Fibrosis Association🇪🇸Valencia, Spain