Assessment of the Dynamic Impact of Non-Invasive Ventilation on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Continuous (24-hour) non-invasive ventilation
- •Patient refusal to participate
- •Individual under legal guardianship or judicial protection
结局指标
主要结局
Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)
时间窗: 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
次要结局
- Changes in transcutaneous carbon dioxide (TcCO₂) levels(Day 1)
- NIV Tolerance(Day 1)
- Pathophysiological type of ALS(Day 1)
- Adherence of NIV(Day 1)