Early initiation of night-time NIV in an outpatient setting

a randomized non-inferiority study in ALS patients

Enrica Bertella, Paolo Banfi, Mara Paneroni, Silvia Grilli, Luca Bianchi, Eleonora Volpato, Michele Vitacca

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Abstract

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.

Original languageEnglish
Pages (from-to)892-899
Number of pages8
JournalEuropean Journal of Physical and Rehabilitation Medicine
Volume53
Issue number6
DOIs
Publication statusPublished - Dec 2017

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Noninvasive Ventilation
Amyotrophic Lateral Sclerosis
Outpatients
Inpatients
Sleep
Spinal Diseases
Blood Gas Analysis
Respiratory Function Tests
Mechanical Ventilators
Patient Compliance
Visual Analog Scale
Dyspnea
Ventilation
Disease Progression
Rehabilitation
Prospective Studies

Keywords

  • Journal Article

Cite this

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title = "Early initiation of night-time NIV in an outpatient setting: a randomized non-inferiority study in ALS patients",
abstract = "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.",
keywords = "Journal Article",
author = "Enrica Bertella and Paolo Banfi and Mara Paneroni and Silvia Grilli and Luca Bianchi and Eleonora Volpato and Michele Vitacca",
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TY - JOUR

T1 - Early initiation of night-time NIV in an outpatient setting

T2 - a randomized non-inferiority study in ALS patients

AU - Bertella, Enrica

AU - Banfi, Paolo

AU - Paneroni, Mara

AU - Grilli, Silvia

AU - Bianchi, Luca

AU - Volpato, Eleonora

AU - Vitacca, Michele

PY - 2017/12

Y1 - 2017/12

N2 - 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.

AB - 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.

KW - Journal Article

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DO - 10.23736/S1973-9087.17.04511-7

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JO - European Journal of Physical and Rehabilitation Medicine

JF - European Journal of Physical and Rehabilitation Medicine

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