Status:
NOT_YET_RECRUITING
Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Amyotrophic lateral sclerosis (ALS) is a rare and serious neurodegenerative disease causing degeneration of motor neurons. . It leads to a progressive paralysis of the muscles involved in voluntary mo...
Eligibility Criteria
Inclusion
- Adult patient (over 18 years old) with a diagnosis of ALS,
- \- Patient who presents with an impairment of the strength of the inspiratory muscles corresponding to the degradation of the Measurement of the maximum inspiratory pressure (MIP) and/or of the inspiratory pressure during the maximum sniffle (SNIP):
- Decrease in SNIP or MIP by 10% of previous values (measured at the last follow-up visit to the center in its standard care)
- If it is his first consultation (no previous value) we will include patients if they have SNIP or MIP values \<90% of the theoretical values provided by the spirometer measuring the pressures. The SNIPs and MIPs (+/-1 standard deviation) must be disturbed for inclusion of the patient.
- Patient not yet using RLX for lung recruitment or Patient using RLX only as a decluttering aid.
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion
- Patient with advanced restrictive impairment = FVC\<50% of theoretical values on inclusion
- Patient with proven alveolar hypoventilation or treated with non-invasive ventilation
- Patient already treated with RLX for pulmonary recruitment
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, minor, and person making object of a legal protection measure: guardianship or curatorship)
- Patient with a contraindication to the use of RLX (1):
- Pneumothorax
- Known intracranial hypertension
- Hemodynamic instability
- Facial or skull surgery \<6 months
- Tracheoesophageal fistula
- Active bleeding
- Untreated active tuberculosis
- Rebellious Hiccup
- the history of known emphysematous or bullous pathologies
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05297487
Start Date
July 1 2025
End Date
July 1 2028
Last Update
September 21 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.