Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD) (PHYSIOMOD)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chest physiotherapy
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cystic fibrosis
- Physiotherapy session is programmed
Exclusion Criteria:
-
Sites / Locations
- Robert Debre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
additional pulmonary function tests
Arm Description
additional pulmonary function tests
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04094441
First Posted
August 19, 2019
Last Updated
February 2, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04094441
Brief Title
Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD)
Acronym
PHYSIOMOD
Official Title
Implementation of Data From Pulmonary Function Tests Supervising a Session of Respiratory Physiotherapy of Cystic Fibrosis Children in the VirtualChest Model
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
January 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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."
Detailed 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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one arm, the interventional design is related to additional pulmonary function tests
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
additional pulmonary function tests
Arm Type
Experimental
Arm Description
additional pulmonary function tests
Intervention Type
Other
Intervention Name(s)
chest physiotherapy
Intervention Description
chest physiotherapy
Primary Outcome Measure Information:
Title
Impedance measurements will be obtained before and after chest physiotherapy using the Impulse Oscillometry System.
Description
Impedance of the respiratory system: Z5Hz, Z10Hz, Z20Hz, Z35Hz, R5Hz (respiratory system resistance), X5Hz (respiratory system reactance), R5-20Hz (difference R5 - R20Hz)
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cystic fibrosis
Physiotherapy session is programmed
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Delclaux, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35729620
Citation
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.
Results Reference
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Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD)
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