dc.contributor
Institut Català de la Salut
dc.contributor
[Sarasate M, Córdoba-Izquierdo A, Prats E] Department of Pneumology, UFIS-Respiratoria, Hospital Universitari de Bellvitge, Barcelona, Spain. [González N] Department of Pneumology, Hospital Residencia Sant Camil, Consorci Sanitari Alt Pendedés-Garraf, Barcelona, Spain. [Rodriguez Gonzalez-Moro JM] Department of Pulmonology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Martí S] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Sarasate, Mikel
dc.contributor.author
González, Nuria
dc.contributor.author
CÓRDOBA-IZQUIERDO, ANA
dc.contributor.author
Prats, Enric
dc.contributor.author
Rodriguez Gonzalez-Moro, Jose Miguel
dc.contributor.author
MARTI, SERGI
dc.date.accessioned
2025-10-24T10:43:35Z
dc.date.available
2025-10-24T10:43:35Z
dc.date.issued
2023-08-10T07:47:56Z
dc.date.issued
2023-08-10T07:47:56Z
dc.identifier
Sarasate M, González N, Córdoba-Izquierdo A, Prats E, Rodriguez Gonzalez-Moro JM, Martí S, et al. Impact of Early Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis: A multicenter Randomized Controlled Trial. J Neuromuscul Dis. 2023;10(4):627–37.
dc.identifier
https://hdl.handle.net/11351/10075
dc.identifier
10.3233/JND-221658
dc.identifier.uri
https://hdl.handle.net/11351/10075
dc.description.abstract
Respiratory complications; Respiratory insufficiency; Survival
dc.description.abstract
Complicaciones respiratorias; Insuficiencia respiratoria; Supervivencia
dc.description.abstract
Complicacions respiratòries; Insuficiència respiratòria; Supervivència
dc.description.abstract
Background and objective:
Forced vital capacity (FVC) less than 50% of predicted is one of the main parameters used for Non-Invasive Ventilation (NIV) initiation in Amyotrophic Lateral Sclerosis (ALS). Recent studies suggest that higher values of FVC could be considered as a threshold. The aim of this study is to evaluate whether early use of NIV improves the prognosis of ALS patients compared with standard initiation.
Methods:
This is a randomized, parallel, multicenter, open-label, controlled clinical trial, with recruitment at the ALS outpatient multidisciplinary units of six Spanish hospitals. Patients were included when their FVC reached the 75% threshold and were randomized by computer, stratifying by center in an allocation ratio of 1:1 to Early NIV (FVC below 75%) or Standard NIV (FVC below 50%) initiation. The primary outcome was time to death or tracheostomy.
Trial registration number ClinicalTrials.gov: NCT01641965.
Results:
Between May 2012 and June 2014, 42 patients were randomized to two groups, 20 to Early NIV and 22 to Standard NIV initiation. We found differences in survival in favor of the intervention group: an incidence of mortality (2.68 [1.87–5.50] vs. 3.33 [1.34–4.80] person-months) and a median survival (25.2 vs. 19.4 months), although without reaching statistical significance (p = 0.267).
Conclusions:
This trial did not reach the primary endpoint of survival; nevertheless, it is the first Randomized Controlled Trial (RCT) to demonstrate the benefits of early NIV in slowing the decline of respiratory muscle strength and reducing adverse events. Although not all the results reached statistical significance, all the analyzed data favor early NIV. In addition, this study demonstrates good tolerance and compliance with early NIV without quality of sleep impairment. These data reinforce the early respiratory evaluation of ALS patients and NIV initiation with an FVC of around 75%.
dc.description.abstract
This study received Health Research Fund (FIS) from Carlos III Health Institute (ISCIII), and a grant from Catalan Society of Pneumology (SOCAP).
dc.format
application/pdf
dc.relation
Journal of Neuromuscular Diseases;10(4)
dc.relation
http://dx.doi.org/10.3233/JND-221658
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Esclerosi lateral amiotròfica - Tractament
dc.subject
Respiració artificial
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Respiració - Mesurament
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DISEASES::Nervous System Diseases::Central Nervous System Diseases::Spinal Cord Diseases::Amyotrophic Lateral Sclerosis
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Other subheadings::Other subheadings::/therapy
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Airway Management::Respiration, Artificial::Noninvasive Ventilation
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PHENOMENA AND PROCESSES::Circulatory and Respiratory Physiological Phenomena::Respiratory Physiological Phenomena::Total Lung Capacity::Vital Capacity
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ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades de la médula espinal::esclerosis lateral amiotrófica
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Otros calificadores::Otros calificadores::/terapia
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::manejo de la via aérea::respiración artificial::ventilación no invasiva
dc.subject
FENÓMENOS Y PROCESOS::fenómenos fisiológicos respiratorios y circulatorios::fenómenos fisiológicos respiratorios::capacidad pulmonar total::capacidad vital
dc.title
Impact of Early Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis: A multicenter Randomized Controlled Trial
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
