Amyotrophic Lateral Sclerosis (ALS), Non Invasive Ventilation (NIV)
Conditions
Keywords
Amyotrophic Lateral Sclerosis (ALS), Non invasive ventilation (NIV), Diaphragmatic ultrasound, diaphragmatic excursion, ultrasound, diaphragmatic thickening
Brief summary
The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and diaphragmatic thickening between spontaneous breathing and non-invasive ventilation ? Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.
Detailed description
Each diaphragmatic ultrasound assessment will be performed on both the right and left hemidiaphragms, with the patient in a semi-recumbent position at 30°, during a maximal inspiratory effort. The following parameters will be measured: * Diaphragmatic excursion using M-mode ultrasound with a low-frequency convex (abdominal) probe via a subcostal approach * Diaphragmatic thickening using B-mode ultrasound with a high-frequency linear (vascular) probe via the lateral axillary line Measurements will be obtained during spontaneous breathing and after 10 to 20 minutes of non-invasive ventilation (NIV), using ventilator settings deemed optimally adjusted by the supervising physician.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (≥18 years old) * Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist * Indication for non-invasive ventilation (NIV) confirmed by the referring pulmonologist for daytime and/or nocturnal alveolar hypoventilation
Exclusion criteria
* Continuous (24-hour) non-invasive ventilation * Patient refusal to participate * Individual under legal guardianship or judicial protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT) | Day 1 | Both DE and DT will be measured under spontaneous bretahing and under NIV. The outcomes will be compared, and the percentage variation between the two conditions will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence of NIV | Day 1 | If a NIV is already instaured, the average adherence in hours per 24 hours will be recorded \- Subgroupes analyses between \< 8 hours/24h NIV adherence, and 8 hours/24h or more NIV adherence |
| Changes in transcutaneous carbon dioxide (TcCO₂) levels | Day 1 | The variation in TcCO₂ will be measured and compared with the variations in DE and DT to determine whether there is a correlation. |
| NIV Tolerance | Day 1 | NIV tolerance will be assessed using a numerical subjective scale from 0 to 10. The tolerance numercial scale will then be compared with variations in DE and DT to determine whether there is a correlation. |
| Pathophysiological type of ALS | Day 1 | For each patient, the bulbar type or the spinal type of ALS will be recorded. Subgroups analyses between spinal ALS and bulbar ALS. Some differences are to be expected. |
Countries
France
Contacts
Primary ContactChristel Saint Raymond, Doctor
Backup ContactHugo Vanderstraete, Resident
Outcome results
None listed