An interventional study of Nightime NIV initiation in Amyotrophic Lateral Sclerosis, sponsored by Fondazione Salvatore Maugeri. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Fondazione Salvatore Maugeri · Not applicable, Interventional, and Treatment
In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV initiated in an outpatient setting can be as effective as regards patients' adherence. The investigators also evaluated factors predicting NIV adherence and disease progression.
All patients with a definite ALS diagnosis, aged > 18 years, referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and Istituto Don Gnocchi Onlus (Milano), Italy, for respiratory functional assessments for the purpose of early initiation of NIV were considered. Patients who were in clinically stable condition and without chest infections during the previous 3 months were considered eligible for the study.
Between March 2011 and March 2014, during an outpatient visit, the patients were randomized 1:1 to two groups for NIV initiation: outpatient vs. inpatient protocol.
In both groups a diurnal NIV initiation trial was performed using pressure-support ventilators in spontaneous/timed mode with a preset tidal volume (300 ml/kg) and a fixed back-up respiratory rate (12 breaths/min). The trial included: choice of the mask, setting of ventilator pressure, at least 2 hours of NIV under supervision.
Then, the patients underwent the nighttime NIV initiation trial for a maximum of 20 nights according to the outpatient vs. inpatient protocol.
NIV trial was stopped when: 1) patients used NIV > 4 hours/night for 3 consecutive nights, 2) patients and caregivers were able to manage with ventilator, 3) patients failed after 10 consecutive educational sessions.
At enrollment (T0), the end of NIV initiation trial (T1) and after 3 months from the end of the trial (T2) respiratory function tests, blood gas analysis, and sleep study were performed.
At T1 the investigators assessed NIV acceptance (as a minimum of 3 consecutive days >4 h/night), and dyspnea symptoms by VAS (day/night), staff and patients' satisfaction.
At T2: NIV adherence (>120 h/month) and patients' satisfaction.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 50 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Fondazione Salvatore Maugeri is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Exclusion Criteria:
In-hospital nightime NIV initiation. For the inpatients Group, NIV was initiated in the respiratory wards of the two hospitals and continued during night for a minimum of 4 hours/night. Inpatients had a 24-h availability of health staff care. During the night, they had nurses and physicians available on-hand.
Procedure: Nightime NIV initiation
Home nightime NIV initiation. For the outpatients group, diurnal NIV was initiated during a scheduled visit in a hospital dedicated room(at least 4 hours/day of care), the trial proceeded at home during the night with a personal caregiver. A minimum of 4 hours/night was required. No support during the night was provided to these patients.
Procedure: Nightime NIV initiation
In-hospital vs home
Adherence as measured by the use of ventilator (hours/month)
Evaluation after 3 months from the end of NIV initiation trial (T2)
Time frame: At 3 months
Changes in respiratory function as assessed by spirometry
Evaluation at 3 months from the end of NIV initiation trial (T2)
Time frame: At 3 months
Changes in dyspnea symptoms as assessed by Visual Analogue Scale
Evaluation at 3 months from the end of NIV initiation trial (T2)
Time frame: At 3 months
Patient's questionnaire of satisfaction
Evaluation at the end of NIV initiation trial (T1)
Time frame: At 20 days
Changes in respiratory function as assessed by Maximal inspiratory pressure/Maximal expiratory pressure
Evaluation at 3 months from the end of NIV initiation trial (T2)
Time frame: At 3 months
Changes in respiratory function as assessed by blood gas analysis
Evaluation at 3 months from the end of NIV initiation trial (T2)
Time frame: At 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Fondazione Salvatore Maugeri