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EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE

A Journal on Physical Medicine and Rehabilitation after Pathological Events


Official Journal of the Italian Society of Physical and Rehabilitation Medicine (SIMFER), European Society of Physical and Rehabilitation Medicine (ESPRM), European Union of Medical Specialists - Physical and Rehabilitation Medicine Section (UEMS-PRM), Mediterranean Forum of Physical and Rehabilitation Medicine (MFPRM), Hellenic Society of Physical and Rehabilitation Medicine (EEFIAP)
In association with International Society of Physical and Rehabilitation Medicine (ISPRM)
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European Journal of Physical and Rehabilitation Medicine 2017 December;53(6):892-9

DOI: 10.23736/S1973-9087.17.04511-7

Copyright © 2017 EDIZIONI MINERVA MEDICA

language: English

Early initiation of night-time NIV in an outpatient setting: a randomized non-inferiority study in ALS patients

Enrica BERTELLA 1 , Paolo BANFI 2, Mara PANERONI 1, Silvia GRILLI 2, Luca BIANCHI 1, Eleonora VOLPATO 2, Michele VITACCA 1

1 Division of Respiratory Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Lumezzane, Brescia, Italy; 2 Don Gnocchi Foundation, S. Maria Nascente Institute for Research and Care, Milan, Italy


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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 in terms of patients’ acceptance/adherence. We also evaluated factors predicting NIV acceptance and adherence and disease progression.
DESIGN: Prospective randomized study.
SETTING: Outpatient versus inpatient rehabilitation.
POPULATION: ALS patients.
METHODS: ALS patients were randomized to two groups for NIV initiation: outpatients versus inpatients. 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.


KEY WORDS: Home care services - Amyotrophic lateral sclerosis - Noninvasive ventilation - Patient compliance

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Publication History

Issue published online: December 12, 2017
Article first published online: April 4, 2017
Manuscript accepted: March 22, 2017
Manuscript revised: February 21, 2017
Manuscript received: September 26, 2016

Cite this article as

Bertella E, Banfi P, Paneroni M, Grilli S, Bianchi L, Volpato E, et al. Early initiation of night-time NIV in an outpatient setting: a randomized non-inferiority study in ALS patients. Eur J Phys Rehabil Med 2017;53:892-9. DOI: 10.23736/S1973-9087.17.04511-7

Corresponding author e-mail

enrica.bertella@icsmaugeri.it