Initiation of Long-term Home Non-invasive Ventilation in ALS Using the iVAPS Mode During a Daytime Trial

Study Purpose:

Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients with ALS with worsening symptoms or deteriorating respiratory function, and has been recommended by the American Academy of Neurology (AAN) practice parameter for ALS. This study will compare the current standard BiST mode of ventilation with the new iVAPS mode.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Marta Kaminska (McGill University Health Center)

Clinicaltrials.gov ID (11 digit #):

NCT01746381

Neals Affiliated?

No

Coordinating Center Contact Information

Montreal Chest Institute
Marta Kaminska, MD,MSc / .(JavaScript must be enabled to view this email address) / 514-934-1934 ext 36117
.(JavaScript must be enabled to view this email address) Montreal, United States

Full Study Summary:

The main study hypothesis is that the iVAPS mode, initiated in a single daytime trial, will result in a reduction of the number of respiratory therapist interventions and changes in ventilator settings as compared with the standard BiST mode. This will be assessed over a period of one year. In addition this study will test whether the iVAPS mode is superior to BiST mode with respect to: comfort and ease of use; improvement in nighttime and daytime symptoms of hypoventilation; compliance (hours used per day); physiologic parameters (daytime and overnight oxygen saturation and transcutaneous CO2 level).

Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients with ALS with worsening symptoms or deteriorating respiratory function, and has been recommended by the American Academy of Neurology (AAN) practice parameter for ALS. The symptomatic and survival benefits offered by NIV to patients with ALS make the optimization of ventilation a priority in terms of physiological variables but also symptoms to improve comfort, and consequently, compliance.

The Intelligent Volume-Assured Pressure Support (iVAPS) is a ventilator mode on the Stellar 150 ventilator (Resmed) that uses an algorithm to target alveolar ventilation. It has a learning mode to determine the initial optimal settings to commence ventilation, and is an adaptive mode, which constantly monitors the patient's spontaneous ventilation and adjusts the level of pressure support to maintain target alveolar ventilation.

The aim of the study is to determine the feasibility of long-term non-invasive home ventilation in ALS patients using the Stellar 150 IVAPS mode, initiated during a single daytime trial, and to assess the number of respiratory therapist interventions subsequently required as well as several patient-centered outcomes. The study will be conducted among patients with ALS referred to the National Program of Home Ventilatory Assistance (NPHVA) at the Montreal Chest Institute. The province-wide program provides home ventilation services to patients with a variety of neuromuscular and other disorders. Referred patients will be randomized to receive traditional Bilevel ventilation in ST mode (BiST) or iVAPS and will be followed over a period of one year. Respiratory therapist interventions (beyond scheduled visits) and changes in ventilator settings will be based on patient complaints and aimed at optimizing patient comfort and ventilator use. In addition, symptoms questionnaires will be administered regularly, home polygraphy (at 1 week), overnight oxymetry and transcutaneous capnography (at 6 and 12 months) will be performed. Compliance data will be assessed regularly from ventilator memory downloads at each of the scheduled respiratory therapist home visits (1 week, 1,6 and 12 months).

Study Sponsor:

Marta Kaminska

Participant Duration:

Estimated Enrollment:

30

Estimated Study Start Date:

01/31/2013

Estimated Study Completion Date:

01/31/2016

Posting Last Modified Date:

02/29/2016

Date Study Added to alsconsortium.org:

12/12/2012
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:
    Patients referred to the National Program of Home Ventilatory Assistance (NPHVA) at the Montreal Chest Institute for home ventilation.
    Patients that meet eligibility criteria for home ventilation as per the Quebec Health Ministry reference frame document for home ventilation (http://publicatio.../11-936-01W.pdf).
    Adequate knowledge of English or French to complete study questionnaires.

    Exclusion Criteria:
    The lack of eligibility for home ventilation, as per the document mentioned above

  • Site Contact Information

    Montreal Chest Institute
    Marta Kaminska, MD,MSc / .(JavaScript must be enabled to view this email address) / 514-934-1934 ext 36117
    Montreal, Quebec H2W2E6
    Canada