Home-Based Adaptation to Night-time Non-invasive Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Randomised Controlled Trial Running Head: Home Adaptation to Non-invasive Ventilation in Amyotrophic Lateral Sclerosis

Abstract

Background: Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS) is generally implemented in an inpatient or outpatient setting.Aims: To investigate whether adaptation to home-based NIV is as effective as outpatient one in ALS in terms of arterial carbon dioxide (PaCO2) improvement. We also evaluated as secondary outcomes NIV acceptance, adherence and patient/caregiver satisfaction, quality of life (QoL) and caregiver burden.Methods: Sixty-six ALS patients with indication for NIV were randomly assigned to two groups: 34 underwent NIV initiation at home (Home Adaptation, HA) and 32 at multiple outpatient visits (Outpatient Adaptation, OA). Respiratory function tests were performed at baseline (T0) together with blood gas analysis, which was repeated at the end of adaptation (T1) and after 2 and 6 months from T1. Overnight cardiorespiratory polygraphy was performed at T0, T2, and T3. NIV acceptance (≥5 hours/night for 3 consecutive nights) and patient's and caregiver's expertise to manage NIV by an educational learning test were measured at T1; NIV adherence (≥150 hours/month) was measured at T2 and T3. Short Form Health Survey (SF-36), Caregiver burden Inventory (CBI), Caregiver burden scale (CBS) and Zarit Burden Interview (ZBI) were performed at T0, T2 and T3.Results: Fifty-eight participants completed the study. No significant differences were found between groups in PaCO2 at T1 (p=0.46), T2 (p=0.50) and T3 (p=0.34) as in acceptance (p=0.55) and adherence to NIV at T2 and T3 (p=0.60 and p=0.75, respectively). At T2, the patients’ QoL, assessed with SF-36, was significantly better in HA than OA (p=0.01), but this improvement was not maintained up to T3 (p = 0.17). Conclusions: In ALS, adaptation to NIV in the patient’s home is effective as that performed in an outpatient setting, in terms of PaCO2 , acceptance and adherence. Improvement in quality of life was also found to be greater at home only after adaptation, opening the need for further studies to understand the role of environment with respect to NIV adherence.

Versorgungsqualität in der außerklinischen Beatmung

“…Auch in Italien konnten positive Effekte im Hinblick auf eine frühe Einleitung einer NIV-Therapie durch die schnellere Verfügbarkeit ohne Unterschiede in der Effektivität oder Akzeptanz gezeigt werden [43,44].…”