Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 521 for:    ALS (Amyotrophic Lateral Sclerosis)

Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01746381
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date August 29, 2019
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Difference in the number of respiratory therapist interventions required using IVAPS vs BIST mode of ventilation in patients with ALS. [ Time Frame: One year ]
The investigators define interventions as any complaint from the patient related to the ventilator that warrants an unscheduled visit from the respiratory therapist or a change in ventilator settings.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
Difference in the number of respiratory therapist interventions required using IVAPS vs BIST mode of ventilation in patients with ALS. [ Time Frame: One year ]
We define interventions as any complaint from the patient related to the ventilator that warrants an unscheduled visit from the respiratory therapist or a change in ventilator settings.
Change History Complete list of historical versions of study NCT01746381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Feasibility of initiating long term home ventilation in ALS patients using the Stellar 150 iVAPS mode during a single daytime trial. [ Time Frame: 1 month ]
    This will be determined by compliance with use of nocturnal ventilation at 1 month, and good control of nocturnal oxygenation and sleep-disordered breathing at 1 week.
  • Difference in symptoms with IVAPS vs. BiST in ALS patients [ Time Frame: 1,6,12 months ]
    The investigators will use a questionnaire to assess hypoventilation-related symptoms and comfort with the ventilator.
  • Effectiveness of ventilation by IVAPS vs. BiST on night-time respiratory parameters in ALS patients [ Time Frame: 1 week, 6 months, 12 months ]
    This will be measured at 1 week using the Embletta portable monitor and transcutaneous capnography, and at 6 and 12 months using overnight oximetry and transcutaneous capnography.
  • Long-term compliance with the use of nocturnal ventilation on IVAPS vs. BiST in ALS patients [ Time Frame: 1,6,12 months ]
    This will be determined by the number of hours use per day recorded by the device.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
  • Feasibility of initiating long term home ventilation in ALS patients using the Stellar 150 iVAPS mode during a single daytime trial. [ Time Frame: 1 month ]
    This will be determined by compliance with use of nocturnal ventilation at 1 month, and good control of nocturnal oxygenation and sleep-disordered breathing at 1 week.
  • Difference in symptoms with IVAPS vs. BiST in ALS patients [ Time Frame: 1,6,12 months ]
    We will use a questionnaire to assess hypoventilation-related symptoms and comfort with the ventilator.
  • Effectiveness of ventilation by IVAPS vs. BiST on night-time respiratory parameters in ALS patients [ Time Frame: 1 week, 6 months, 12 months ]
    This will be measured at 1 week using the Embletta portable monitor and transcutaneous capnography, and at 6 and 12 months using overnight oximetry and transcutaneous capnography.
  • Long-term compliance with the use of nocturnal ventilation on IVAPS vs. BiST in ALS patients [ Time Frame: 1,6,12 months ]
    This will be determined by the number of hours use per day recorded by the device.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode
Official Title  ICMJE Initiation of Long-term Home Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode During a Daytime Trial
Brief Summary

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. 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).

Detailed Description

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder that is incurable, progressive, manifested by muscle weakness and wasting, and caused by degeneration of motor neurones. The limited data available suggest the incidence of ALS in Canada to be approximately 2 per 100,000 persons. The disease is characterized by progressive weakness of respiratory muscles, leading to respiratory insufficiency which is often the cause of death in patients with ALS.

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, 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE Device: Non-invasive home ventilation
A ventilator and mask will be provided to patients according to standard procedures used at the National Program of Home Ventilatory Assistance of the Montreal Chest Institute, adjusted during a daytime outpatient trial, with close follow-up as described in study protocol.
Other Name: Resmed Stellar 150
Study Arms  ICMJE
  • Experimental: IVAPS mode of non-invasive ventilation
    Patients with ALS randomized to this arm will be treated with non-invasive home ventilation using the Intelligent Volume-Assured Pressure Support (IVAPS) mode
    Intervention: Device: Non-invasive home ventilation
  • Active Comparator: BIST mode of non-invasive ventilation
    Patients with ALS who are randomized to this arm will receive non-invasive home ventilation with the traditional bilevel non-invasive ventilation in spontaneous/timed (BIST) mode
    Intervention: Device: Non-invasive home ventilation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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://publications.msss.gouv.qc.ca/acrobat/f/documentation/2011/11-936-01W.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
  • Active cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01746381
Other Study ID Numbers  ICMJE 2902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE Marta Kaminska
Collaborators  ICMJE ResMed
Investigators  ICMJE
Principal Investigator: Marta Kaminska, MD,MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Rita Troini, RRT,MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP