Informations générales (source: ClinicalTrials.gov)
Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients (MUCOSIM)
Interventional
N/A
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche (Voir sur ClinicalTrials)
septembre 2019
décembre 2023
06 juillet 2024
The main objective of the study is to evaluate the short-term effects of the airway
clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic
Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To
analyse these effects, the investigators used forced oscillation technique measured by
TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc.
Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| SOINS DE SUITE FONDATION ROTHSCHILD | Thomas ROPARS, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Amiens - Amiens - France | Claire POULET, MD | Contact (sur clinicalTrials) | |||
| CH Nice - Nice - France | Sylvie LEROY, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille - Hopital Calmette - Lille - France | Thierry PEREZ, MD | Contact (sur clinicalTrials) | |||
| GH Sud - Hospices Civils de Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Larrey - Toulouse - France | Marlène MURRIS-ESPIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Rouen - Rouen - France | Stephane DOMINIQUE, MD | Contact (sur clinicalTrials) | |||
| Hôpital la Bocage CHRU de Dijon - Dijon - France | Guillaume BELTRAMO, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% <FEV1 <70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% <FEV1 <70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
- Uncontrolled asthma
- Pneumothorax <6 weeks
- Recent severe hemoptysis <6 weeks
- Patient registered on the transplant list
- Exacerbation within 4 weeks (3 months if hospitalization) before screening
- Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically
significant respiratory (non-cystic fibrosis) conditions
- Patients unable to perform measurements of ROF, spirometry, plethysmography.
- Any contraindication to manual or instrumental physiotherapy.
- Pregnancy, breastfeeding.
- Patient under tutorship or curatorship
- No affiliation to the French social security
- Patient using Simeox at home
- Patient under Trikafta for less than 6 weeks.
- Patient using Simeox more than twice a week during physiotherapy sessions, not
wanting a washout period of 7 days before inclusion