Cystic Fibrosis
Conditions
Brief summary
This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage. This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis. Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.
Interventions
OTHERAutogenic drainage
Autogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session.
DEVICESIMEOX + Autogenic drainage
SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults with cystic fibrosis * Chronic bronchorrhea, able to expectorate by themselves * Hospitalized
Exclusion criteria
* Regular use of SIMEOX, * Difficulties in understanding instructions, * Severe cardiac comorbidity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of sputum secretion | 30-min | Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified. |
| Mucus viscoelasticity | 30-min | Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention. |
| Subjective feeling of ease to expectorate | 3-min | A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention. The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where 0 indicates very easy to expectorate and 10 indicates not easy to expectorate at all. The lower the score, the easier it is to expectorate. |
Countries
Belgium
Outcome results
None listed