Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Nightime Noninvasive Mechanical Ventilation Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting. A Non-inferiority Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759003
• Other study ID #: CTS 02/2011
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 3, 2016
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2016
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Procedure:
• Nightime NIV initiation
In-hospital vs home

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri	Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence as measured by the use of ventilator (hours/month)	Evaluation after 3 months from the end of NIV initiation trial (T2)	At 3 months	No
Secondary	Changes in respiratory function as assessed by spirometry	Evaluation at 3 months from the end of NIV initiation trial (T2)	At 3 months	No
Secondary	Changes in dyspnea symptoms as assessed by Visual Analogue Scale	Evaluation at 3 months from the end of NIV initiation trial (T2)	At 3 months	No
Secondary	Patient's questionnaire of satisfaction	Evaluation at the end of NIV initiation trial (T1)	At 20 days	No
Secondary	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)	At 3 months	No
Secondary	Changes in respiratory function as assessed by blood gas analysis	Evaluation at 3 months from the end of NIV initiation trial (T2)	At 3 months	No