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Trial record 82 of 677 for:    amyotrophic lateral sclerosis

Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting

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ClinicalTrials.gov Identifier: NCT02759003
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : May 4, 2016
Sponsor:
Collaborator:
Fondazione Don Carlo Gnocchi Onlus
Information provided by (Responsible Party):
Enrica Bertella, Fondazione Salvatore Maugeri

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Nightime NIV initiation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nightime Noninvasive Mechanical Ventilation Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting. A Non-inferiority Study.
Study Start Date : March 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014


Arm Intervention/treatment
Active Comparator: 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.

Procedure: Nightime NIV initiation
In-hospital vs home

Experimental: 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.

Procedure: Nightime NIV initiation
In-hospital vs home




Primary Outcome Measures :
  1. Adherence as measured by the use of ventilator (hours/month) [ Time Frame: At 3 months ]
    Evaluation after 3 months from the end of NIV initiation trial (T2)


Secondary Outcome Measures :
  1. Changes in respiratory function as assessed by spirometry [ Time Frame: At 3 months ]
    Evaluation at 3 months from the end of NIV initiation trial (T2)

  2. Changes in dyspnea symptoms as assessed by Visual Analogue Scale [ Time Frame: At 3 months ]
    Evaluation at 3 months from the end of NIV initiation trial (T2)

  3. Patient's questionnaire of satisfaction [ Time Frame: At 20 days ]
    Evaluation at the end of NIV initiation trial (T1)

  4. Changes in respiratory function as assessed by Maximal inspiratory pressure/Maximal expiratory pressure [ Time Frame: At 3 months ]
    Evaluation at 3 months from the end of NIV initiation trial (T2)

  5. Changes in respiratory function as assessed by blood gas analysis [ Time Frame: At 3 months ]
    Evaluation at 3 months from the end of NIV initiation trial (T2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759003


Sponsors and Collaborators
Fondazione Salvatore Maugeri
Fondazione Don Carlo Gnocchi Onlus
Investigators
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Principal Investigator: Enrica Bertella, MD Fondazione Salvatore Maugeri

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Responsible Party: Enrica Bertella, Principal Investigator, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT02759003     History of Changes
Other Study ID Numbers: CTS 02/2011
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases