Cystic Fibrosis
Conditions
Keywords
physiotherapy, pulmonary function
Brief summary
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).
Detailed description
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.
Interventions
DEVICEPEP-MASK
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.
Intervention model description
Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* CF diagnosis * Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre * ≥ 15 kilograms * FEV1 ≥ 40%predicted * Ability to perform NMBW test * Ability to perform spirometry * Willing to adhere to protocol procedures * Patients in treatment with PEP-MASK
Exclusion criteria
* Pulmonary Exacerbation within two last week * Burkholderia cepacia infection * Patients in lung transplantation waiting list * Patients undergoing non invasive mechanical ventilation or oxygen therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of PEP-MASK on ventilation heterogeneity (Sacin) | Right after intervention/sham procedure | Acinar airways (Sacin) mean difference between treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of PEP-MASK on ventilation heterogeneity (Scond) | Right after intervention/sham procedure | Conductive airways (Scond) mean difference between treatments |
| Effect of PEP-MASK on ventilation heterogeneity (LCI) | Right after intervention/sham procedure | Ventilation heterogeneity (LCI) mean difference between treatments |
| Sputum weight | From the beginning to the end of each intervention/sham procedure | Sputum weight (grams) will be collected throughout the active or sham interventions |
| Oxygen saturation | From the beginning to the end of each intervention/sham procedure | Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions |
Countries
Italy
Outcome results
None listed