TY - JOUR
T1 - Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial
AU - Volpato, Eleonora
AU - Vitacca, Michele
AU - Ptacinsky, Luciana
AU - Lax, Agata
AU - D’Ascenzo, Salvatore
AU - Bertella, Enrica
AU - Paneroni, Mara
AU - Grilli, Silvia
AU - Banfi, Paolo
PY - 2022
Y1 - 2022
N2 - Background: Initiation to Non-Invasive Ventilation (NIV) in amyotrophic lateral sclerosis
(ALS) can be implemented in an inpatient or outpatient setting. Aims: We aimed to evaluate the
efficacy of adaptation (the number of needed sessions) to home-based NIV compared to an outpatient
one in ALS in terms of arterial carbon dioxide (PaCO2) improvement. NIV acceptance (mean use of ≥5
h NIV per night for three consecutive nights during the adaptation trial), adherence (night-time NIV
usage for ≥150 h/month), quality of life (QoL), and caregiver burden were secondary outcomes.
Methods: A total of 66 ALS patients with indications for NIV were involved in this randomized
controlled trial (RCT): 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
(the time of starting the NIV, T0) together with blood gas analysis, which was repeated at the end of
adaptation (T1) and 2 (T2) and 6 (T3) months after T1. NIV adherence was measured at T2 and T3.
Overnight cardiorespiratory polygraphy, 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 differences were found
between groups in PaCO2 at T1 (p = 0.46), T2 (p = 0.50), and T3 (p = 0.34) 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 in OA (p = 0.01), but this improvement was not
maintained until T3 (p = 0.17). Conclusions: In ALS, adaptation to NIV in the patient’s home is as
effective as that performed in an outpatient setting regarding PaCO2, acceptance, and adherence,
which emphasizes the need for further studies to understand the role of the environment concerning
NIV adherence.
AB - Background: Initiation to Non-Invasive Ventilation (NIV) in amyotrophic lateral sclerosis
(ALS) can be implemented in an inpatient or outpatient setting. Aims: We aimed to evaluate the
efficacy of adaptation (the number of needed sessions) to home-based NIV compared to an outpatient
one in ALS in terms of arterial carbon dioxide (PaCO2) improvement. NIV acceptance (mean use of ≥5
h NIV per night for three consecutive nights during the adaptation trial), adherence (night-time NIV
usage for ≥150 h/month), quality of life (QoL), and caregiver burden were secondary outcomes.
Methods: A total of 66 ALS patients with indications for NIV were involved in this randomized
controlled trial (RCT): 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
(the time of starting the NIV, T0) together with blood gas analysis, which was repeated at the end of
adaptation (T1) and 2 (T2) and 6 (T3) months after T1. NIV adherence was measured at T2 and T3.
Overnight cardiorespiratory polygraphy, 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 differences were found
between groups in PaCO2 at T1 (p = 0.46), T2 (p = 0.50), and T3 (p = 0.34) 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 in OA (p = 0.01), but this improvement was not
maintained until T3 (p = 0.17). Conclusions: In ALS, adaptation to NIV in the patient’s home is as
effective as that performed in an outpatient setting regarding PaCO2, acceptance, and adherence,
which emphasizes the need for further studies to understand the role of the environment concerning
NIV adherence.
KW - Amyotrophic Lateral Sclerosis (ALS)
KW - Home Non Invasive Ventilation
KW - Quality of Life (QoL)
KW - Amyotrophic Lateral Sclerosis (ALS)
KW - Home Non Invasive Ventilation
KW - Quality of Life (QoL)
UR - http://hdl.handle.net/10807/210682
U2 - 10.3390/jcm11113178
DO - 10.3390/jcm11113178
M3 - Article
SN - 2077-0383
VL - 11
SP - 1
EP - 17
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
ER -