Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Impact of Early Non-invasive Ventilation in Amyotrophic Lateral Sclerosis Patients: a Randomized Controlled Trial
Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral
sclerosis patients remains unclear. The hypothesis of the study is that the early use of
NIV, in the initial phase of respiratory muscle weakness, improves the prognosis of ALS
patients.
Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.
Secondary objectives:To determine the effects from early NIV in the progression of
respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of
ALS patients. To evaluate the correlation between the FVC and other parameters of
respiratory evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure
(SNP), nocturnal desaturation) and their utility in the early indication of the NIV. To
evaluate the tolerance to the early NIV.
Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel
treatment design. Patients will be included when their FVC reaches the threshold of the 75%
of the predicted value and will be randomized in: Group A: the NIV treatment will begin
immediately and Group B: the NIV treatment will be started when patients fulfil at least one
of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45
mmHg. Follow-up visits will be done every three months with pulmonary function test,
nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease
progression (ALSFSR-R scale), tolerance and compliance with NIV.
ALS patients with early impairment of respiratory muscles (FVC around 75%) will be radomised
to initiate NIV or conventional follow-up.
The NIV treatment will be initiated during a hospital with the model of ventilator VIVO 40
(BREAS Medical AD, Sweden) using a pressure support assisted/control mode, with a minimum
pressure support 10 cm.
Initial NIV indication in both groups of patients will nocturnal. Patients will be defined
as tolerant to NIV if they do not refer inconveniences and is able to asleep with NIV.
The efficacy of the intervention will be compared in both groups with survival until death
or change to invasive tracheal ventilation as a prymary efficacy parameter.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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