Short-term Effects of Physiotherapy on LCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: PEP-MASK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEP standard<br> | Device: PEP-MASK<br> <br> |
| Sham Comparator: PEP sham<br> | Device: PEP-MASK<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PEP-MASK on ventilation heterogeneity (Sacin) | Acinar airways (Sacin) mean difference between treatments | Right after intervention/sham procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PEP-MASK on ventilation heterogeneity (Scond) | Conductive airways (Scond) mean difference between treatments | Right after intervention/sham procedure | 
| Effect of PEP-MASK on ventilation heterogeneity (LCI) | Ventilation heterogeneity (LCI) mean difference between treatments | Right after intervention/sham procedure | 
| Sputum weight | Sputum weight (grams) will be collected throughout the active or sham interventions | 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 | From the beginning to the end of each intervention/sham procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiotherapy, pulmonary function