Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD)

Cystic Fibrosis Clinical Trial

— PHYSIOMOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094441
• Other study ID #: N° IDRCB: 2017-A02426-47
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: January 10, 2021

Study information

• Verified date: August 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"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."

Description:

"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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 10, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cystic fibrosis

• Physiotherapy session is programmed

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• chest physiotherapy
chest physiotherapy

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Bokov P, Gerardin M, Brialix G, Da Costa Noble E, Juif R, Foucher AV, Le Clainche L, Houdouin V, Mauroy B, Delclaux C. Beneficial short-term effect of autogenic drainage on peripheral resistance in childhood cystic fibrosis disease. BMC Pulm Med. 2022 Jun 21;22(1):241. doi: 10.1186/s12890-022-02039-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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