Status:
ACTIVE_NOT_RECRUITING
Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Neuromuscular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial sup...
Detailed Description
This is a bicentric, prospective crossover, randomized, open label trial. The study will focus on 50 adult patients with stable neuromuscular conditions, outside the congestion period requiring cough ...
Eligibility Criteria
Inclusion
- Aged ≥18 years
- Neuromuscular pathology
- Coughing aid information: DEPT \<180 l / min
- In stable condition and without bulk
- Good understanding and cognition to follow the instructions and to inform the EVA
- Affiliated to a Sickness Insurance Plan or entitled
- Signed of informed consent
Exclusion
- Pregnant woman
- Person under guardianship
- Inability to cooperate and / or communicate
- Acute decompensated organ
- Patient with following contraindications to mechanical in-exsufflation (MI-E) devices:
- pneumothorax
- pneumomediastinum
- pulmonary emphysema
- hemoptysis
- pleurisy
- nausea
- obstructive pulmonary disease or asthma
- recent lobectomy of the lung
- intracranial pressure
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03355105
Start Date
March 7 2019
End Date
December 24 2024
Last Update
June 11 2024
Active Locations (1)
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1
Department of Physiology and Functional Explorations, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, France, 92380