The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition.
Michele Vitacca
Lumezzane, Brescia, Italy
Paolo Banfi
Milan, Italy
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
Time frame: Baseline + after 2 and 4 months from the recruitment
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