Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Continuous (24-hour) non-invasive ventilation
Patient refusal to participate
Individual under legal guardianship or judicial protection
Trial population
Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)
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
Time frame
Day 1Secondary outcomes
1
Changes in transcutaneous carbon dioxide (TcCO₂) levels
The variation in TcCO₂ will be measured and compared with the variations in DE and DT to determine whether there is a correlation.
Time frame
Day 12
NIV Tolerance
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.
Time frame
Day 13
Pathophysiological type of ALS
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.
Time frame
Day 14
Adherence of NIV
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
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: