Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and … (NCT04010253) | Clinical Trial Compass
CompletedNot Applicable
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
France31 participantsStarted 2019-09-30
Plain-language summary
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 TremoFloâ„¢ C-100 Airwave Oscillometry Systemâ„¢ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
* 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
What they're measuring
1
Low frequency resistance R5
Timeframe: 1 month
Trial details
NCT IDNCT04010253
SponsorAssociation Nationale pour les Traitements A Domicile, les Innovations et la Recherche