Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD)

Study Overview
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Brief Summary
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The usefulness of respiratory physiotherapy and its execution modalities remains highly debated even though reviews of the literature show that respiratory physiotherapy is able to improve the drainage of bronchial secretions and pulmonary function tests during cystic fibrosis in periods of stability. Different physiotherapy techniques have been developed but the choice of one or the other facing a patient can not currently be recommended. The VirtualChest project, supported by a grant from the National Agency for Research (ANR), aims to develop and validate a physical model of respiratory physiotherapy (6 stages including model establishment pulmonary: bronchial tree and pulmonary mechanics and parietal [steps 1 and 3], a model of mucus [step 2] and modeling the effect of physiotherapy [step 5]). This project is integrated with stages 3 and 5 of this broad project and aims to get on a limited number of children with cystic fibrosis a proof of concept (prediction of drainage efficiency) and especially to feed the proposed physical models in order to subsequent optimization of the model (step 6). The choice cystic fibrosis of the child was justified by the effect demonstrated respiratory physiotherapy, particularly on respiratory functional criteria, and the fact that the parietal mechanics varies physiologically at this age.

Detailed Description
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The clinical study will consist in carrying out, before and after hospital respiratory physiotherapy, a measure impedance of the respiratory system by forced oscillations (IOS, impulsometry: measurement during tidal breathing) and a measurement anatomical dead space (duration of the two measurements: 10 minutes). The physiotherapist will make an initial diagnosis (degree of bronchial obstruction), fill a form describing the modalities of the physiotherapy session (methods used) and will evaluate the sputum volume got. On a limited number of children (n = 6), expiratory flow will be measured during the session of physiotherapy ; these measures will be carried out in hypersecreting children able to support a face mask during the session and having had or before have a chest CT scan within 6 months. The objective is to establish a correlation between sputum volume and the degree of improvement of functional respiratory parameters, to establish criteria of central and / or peripheral effect of physiotherapy (simple modeling obtained from measurements impedance of the respiratory system) and to obtain the flow rates necessary and sufficient to mobilize bronchial secretions. The data from this phase will allow to fuel the complex physical model (distribution mucus in the airways). Moreover, for each of the patients will be recovered the possible scanner performed within ± 6 months of the physiotherapy session which will allow the extraction of the morphology of the airways of the patient. The goal is to get in at least 6 patients a specific morphology of the airways and determine if this morphology implementation allows to improve the model compared to the use of generic modeling or airway tree. A total of 30 elderly Cystic Fibrosis children at least 4 years will be prospectively included.

Official Title
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Implementation of Data From Pulmonary Function Tests Supervising a Session of Respiratory Physiotherapy of Cystic Fibrosis Children in the VirtualChest Model

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: chest physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cystic fibrosis Physiotherapy session is programmed Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 4 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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: one arm, the interventional design is related to additional pulmonary function tests
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: additional pulmonary function tests<br>additional pulmonary function tests | Other: chest physiotherapy<br>* chest physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impedance measurements will be obtained before and after chest physiotherapy using the Impulse Oscillometry System. | Impedance of the respiratory system: Z5Hz, Z10Hz, Z20Hz, Z35Hz, R5Hz (respiratory system resistance), X5Hz (respiratory system reactance), R5-20Hz (difference R5 - R20Hz) | 2 hours |