Nightime Noninvasive Mechanical Ventilation Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting. A Non-inferiority Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Adherence as measured by the use of ventilator (hours/month)
研究概览
简要总结
In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV initiated in an outpatient setting can be as effective as regards patients' adherence. The investigators also evaluated factors predicting NIV adherence and disease progression.
详细描述
All patients with a definite ALS diagnosis, aged > 18 years, referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and Istituto Don Gnocchi Onlus (Milano), Italy, for respiratory functional assessments for the purpose of early initiation of NIV were considered. Patients who were in clinically stable condition and without chest infections during the previous 3 months were considered eligible for the study.
Between March 2011 and March 2014, during an outpatient visit, the patients were randomized 1:1 to two groups for NIV initiation: outpatient vs. inpatient protocol.
In both groups a diurnal NIV initiation trial was performed using pressure-support ventilators in spontaneous/timed mode with a preset tidal volume (300 ml/kg) and a fixed back-up respiratory rate (12 breaths/min). The trial included: choice of the mask, setting of ventilator pressure, at least 2 hours of NIV under supervision.
Then, the patients underwent the nighttime NIV initiation trial for a maximum of 20 nights according to the outpatient vs. inpatient protocol.
NIV trial was stopped when: 1) patients used NIV > 4 hours/night for 3 consecutive nights, 2) patients and caregivers were able to manage with ventilator, 3) patients failed after 10 consecutive educational sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •consecutive patients
- •definite ALS diagnosis
- •aged > 18 years
- •in clinically stable condition
- •referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and the Istituto Don Gnocchi Onlus (Milano), Italy for respiratory functional assessment for the purpose of early initiation of NIV
- •no chest infections during the previous 3 months.
排除标准
- •cognitive impairment
- •refusal to participate
- •severe comorbidities and contraindications to NIV (arrhythmias, cardiac failure, history of pneumothorax)
- •distance from hospital > 40 km, travel problems to attend the outpatient clinic
结局指标
主要结局
Adherence as measured by the use of ventilator (hours/month)
时间窗: At 3 months
Evaluation after 3 months from the end of NIV initiation trial (T2)
次要结局
- Changes in dyspnea symptoms as assessed by Visual Analogue Scale(At 3 months)
- Changes in respiratory function as assessed by Maximal inspiratory pressure/Maximal expiratory pressure(At 3 months)
- Patient's questionnaire of satisfaction(At 20 days)
- Changes in respiratory function as assessed by spirometry(At 3 months)
- Changes in respiratory function as assessed by blood gas analysis(At 3 months)
研究者
Enrica Bertella
Principal Investigator
Fondazione Salvatore Maugeri