Neuromuscular Disease Clinical Trial
— LIAMOfficial title:
Long-Term Effect of LIAM (Lung Insufflation Assist Maneuver) on Respiratory Performance in Non-invasive Ventilated Patients Suffering From Neuromuscular Disease
The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be assessed in a prospective, randomized, cross over, open label study
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - o neuromuscular disease ( progressive muscular dystrophy, for example; Duchenne muscular dystrophy, spinal muscular atrophy) - age = 18 years - indication to NIV (ongoing ventilation or new patients) - vital capacity = 50% pred - peak cough flow < 270 l/min - "LIAM Responder" = increased insufflation capacity (= + 50%) and Peak Cough Flow (PCF =+ 50%) with LIAM Exclusion Criteria: - o acute respiratory failure (respiratory acidosis) - home treatment by instrumental cough assistance in the preceding 12 months - ongoing medical treatment of the neuromuscular disease (for ex: corticosteroids in Duchenne disease, enzyme therapy in Pompe disease) - previous pneumothorax - plan of legal protection - pregnant or breastfeeding women - failure to cooperate - no affiliation to a social security scheme |
Country | Name | City | State |
---|---|---|---|
France | Home ventilation Unit , Raymond Poincaré hospital | Garches | Paris Area |
Lead Sponsor | Collaborator |
---|---|
Centre d'Investigation Clinique et Technologique 805 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the maximal assisted vital capacity (maximal insufflation capacity) between the begin of the treatment period and the 3-months follow up | Change in the maximal assisted vital capacity (maximal insufflation capacity) between the begin of the treatment period and the 3-months follow up | 15 minutes | |
Secondary | spontaneous vital capacity | spontaneous vital capacity change at 3 months | 15 minutes | |
Secondary | peak flow | peak cough flow (spontaneous / assisted) change at 3 months | 15 minutes | |
Secondary | optoelectronic plethysmography | change at 3 months in the distribution in ventilation (assessed by optoelectronic plethysmography), spontaneous/assisted | 1 hour |
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