Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting

NCT ID: NCT02759003

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inpatients group

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.

Group Type: ACTIVE_COMPARATOR

Nightime NIV initiation

Intervention Type: PROCEDURE

In-hospital vs home

outpatients group

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.

Group Type: EXPERIMENTAL

Nightime NIV initiation

Intervention Type: PROCEDURE

In-hospital vs home

Interventions

Nightime NIV initiation

In-hospital vs home

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• consecutive patients
• definite ALS diagnosis
• aged > 18 years
• in clinically stable condition
• referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and the Istituto Don Gnocchi Onlus (Milano), Italy for respiratory functional assessment for the purpose of early initiation of NIV
• no chest infections during the previous 3 months.

Exclusion Criteria

• cognitive impairment
• refusal to participate
• severe comorbidities and contraindications to NIV (arrhythmias, cardiac failure, history of pneumothorax)
• distance from hospital > 40 km, travel problems to attend the outpatient clinic

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: collaborator

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Enrica Bertella

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrica Bertella, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri

Other Identifiers

CTS 02/2011

Identifier Type: -

Identifier Source: org_study_id