Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF). The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask. Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity. Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Azienda Ospedaliero-Universitaria Meyer
Florence, Italy
Centro Regionale di Riferimento Fibrosi Cistica
Milan, Italy
Effect of PEP-MASK on ventilation heterogeneity (Sacin)
Acinar airways (Sacin) mean difference between treatments
Time frame: Right after intervention/sham procedure
Effect of PEP-MASK on ventilation heterogeneity (Scond)
Conductive airways (Scond) mean difference between treatments
Time frame: Right after intervention/sham procedure
Effect of PEP-MASK on ventilation heterogeneity (LCI)
Ventilation heterogeneity (LCI) mean difference between treatments
Time frame: Right after intervention/sham procedure
Sputum weight
Sputum weight (grams) will be collected throughout the active or sham interventions
Time frame: From the beginning to the end of each intervention/sham procedure
Oxygen saturation
Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions
Time frame: From the beginning to the end of each intervention/sham procedure
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