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EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE

Rivista di Medicina Fisica e Riabilitativa dopo Eventi Patologici


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)
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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

lingua: Inglese

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

Per citare questo articolo

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