Early initiation of nighttime NIV in an outpatient setting. A randomized non inferiority study in ALS patients

BACKGROUND: In patients with amyotrophic lateral sclerosis (ALS), non-invasive ventilation (NIV) is usually initiated in an in-hospital regime. AIM: We investigated if NIV initiated in an outpatient setting can be as effective as regards patients' acceptance/adherence. We also evaluated factors predicting NIV acceptance and adherence and disease progression. DESIGN: Prospective randomized study. SETTING: Outpatient vs inpatient rehabilitation. POPULATION: ALS patients. METHODS: ALS patients were randomized to two groups for NIV initiation: outpatient vs. inpatient. At baseline (T0), end of NIV trial program (T1) and after 3 months from T1 (T2), respiratory function tests, blood gas analysis, and sleep study were performed. At T1, we assessed: NIV acceptance (>4 h/night), and dyspnea symptoms (day/night) by Visual analogue scale (VAS), staff and patients' experience (how difficult NIV was to accept, how difficult ventilator was to manage, satisfaction); at T2: NIV adherence (>120 h/month) and patients' experience. RESULTS: Fifty patients participated. There were no differences in acceptance failure (p=0.733) or adherence failure (p=0.529). At T1, outpatients had longer hours of nocturnal ventilation (p<0.02), at T2 this was similar (p=0.34). Female gender and spinal onset of the disease were predictors for NIV acceptance/adherence failure. There were no between-group differences in progression of respiratory impairment, symptoms and sleep quality. CONCLUSIONS: Early outpatient initiation of NIV in ALS is as effective as inpatient initiation