Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Early Surgical Clinical Score
研究概览
简要总结
To compensate for insufficiency of diagnostic tools, the present study propose to look for the predictive factors of an early fitting by noninvasive ventilation.
详细描述
Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease. The diagnosis of this diaphragmatic dysfunction in the ALS subject is done all too often on the occasion of a hospitalization for acute respiratory insufficiency, which aggravates then the prognosis of the patients.
The presence of these factors at diagnosis will allow more surveillance to detect early diaphragmatic insufficiency and establish a NIV (Non Invasive Ventilation), the only therapeutic measure definitely improving the quality of life and survival of patients. A clinical score will be established to determine the risk of early Non Invasive Ventilation (NIV) equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •diagnosis of amyotrophic lateral sclerosis just performed,
- •Patient who do not have the criteria for fitting by NIV and who have a Vital capacity ≥ 70% of theoretical values
排除标准
- •Patient under court bail/ guardianship
- •Lack of consent for participation in the study
- •Presence of criteria for setting up the NIV for diagnosis according to the HAS (HealthCare Analytics Summit) 2006 recommendations
- •Vital capacity <70% of the theoretical values
- •Patient under Continuous Positive Pressure (CPP) or NIV for a respiratory pathology other
研究组 & 干预措施
patients with a NIV equipment
Determination of diagnosis variables in a group of patient who benefit of the Non Invasive ventilation equipment one year after the diagnostic
干预措施: diagnosis variables (Diagnostic Test)
patients without a NIV equipment
Determination of diagnosis variables in a group of patient who not benefit of the Non Invasive ventilation equipment one year after the diagnostic
干预措施: diagnosis variables (Diagnostic Test)
结局指标
主要结局
Early Surgical Clinical Score
时间窗: One year after diagnostic
An Early Surgical Clinical Score will be established taking into account the independent variables correlated to diagnosis at early fitting. Clinical Variables : * Presence of bulbar involvement or not * Time from onset of first symptoms to diagnosis * Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) score : The Amyotrophic Lateral Sclerosis Functional Ra ting Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time. * Presence of another underlying respiratory disease Functional Variables : * Time from onset of first symptoms to diagnosis of ALS * Presence of another underlying respiratory pathology * Forced Vital Capacity (FVC) measurement * PaCO2 measurement * Measure Sniff Nasal Inspiratory Pressure (SNIP) * Measurement of diaphragmatic activity on ultrasound * Parameters of the Polysomnography (PSG)
次要结局
- Sensitivity, specificity, negative and positive predictive values(One year after the diagnostic)
- Percentage of decrease(One year after the diagnostic)
- Slope of FVC decline(One year after the diagnostic)
- Quality of life score(One year after the diagnostic)