Mukowiscydoza: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (33)

1. Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:
2. SIMEOX,
3. an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
4. intrapulmonary percussion ventilation (IPV)
5. Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
6. a mechanical in-exsufflator (MI E) such as the Cough Assist
7. a pressure reducer such as the Alpha300
8. Cystic fibrosis
9. Predominant diagnosis of Chronic obstructive pulmonary disease (COPD) or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
10. Active smoking
11. Suspected (but undiagnosed) or unstabilised immune deficiency (at investigator's discretion)
12. In the case of long-term immunosuppressive treatment, risk of discontinuation of this treatment during the study.
13. Unstable cardiovascular pathologies (acute coronary syndrome, unstable angina pectoris, uncontrolled rhythm disorders, unstable heart failure)
14. Haemodynamic instability
15. Uncontrolled gastro-oesophageal reflux (persistence of symptoms despite treatment), at investigator's discretion.
16. Acute pneumothorax or increased susceptibility to pneumothorax/pneumomediastinum
17. Inability to cough vigorously and independently, at investigator's discretion
18. Had a significant episode of haemoptysis in the 6 weeks prior to inclusion, at the discretion of the investigator
19. Patient using an endotracheal tube, tracheostomy tube or daytime ventilation >16h with a mask
20. Patients with neuromuscular disease and respiratory muscle weakness, at the discretion of the investigator
21. Recent cardiothoracic surgery, including oesophageal surgery within 3 months of inclusion
22. Severe acute lung injury or barotrauma within 3 months of inclusion
23. Difficulty in evacuating secretions from the upper airways due to weakness of the respiratory muscles, or of the oropharyngeal or buccal musculature, at the discretion of the investigator
24. Risk of airway aspiration, e.g. from tube feeding or recent meals, at investigator's discretion
25. Inspiratory muscle weakness with inability to tolerate increased work of breathing, at investigator's discretion
26. Severe restrictive disease (Total Lung Capacity < 60% with complete plethysmography)
27. Bullous emphysema
28. Participation in other interventional clinical study in the month prior to inclusion or during the study period
29. Patient unavailable or wishing to move to a region where the protocol is not present before the end of their participation
30. Vulnerable people:
31. pregnant women (verified by a urine or blood human chorionic gonadotropin (HCG) test for all women wishing to participate in the protocol and of childbearing age, without contraception), breastfeeding mothers or women planning to become pregnant during the period of participation in the clinical investigation
32. a person deprived of liberty by judicial or administrative decision
33. a person subject to a legal protection measure