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

NCT01746381 | Completed

• 1 other identifier: 2902
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

amyotrophic lateral sclerosis; non-invasive ventilation; home ventilation; IVAPS; neuromuscular diseases

Outcome Measures

Primary Outcomes (1)

• Difference in the number of respiratory therapist interventions required using IVAPS vs BIST mode of ventilation in patients with ALS.

  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.

  One year

Secondary Outcomes (4)

• Feasibility of initiating long term home ventilation in ALS patients using the Stellar 150 iVAPS mode during a single daytime trial.

  1 month

• Difference in symptoms with IVAPS vs. BiST in ALS patients

  1,6,12 months

• Effectiveness of ventilation by IVAPS vs. BiST on night-time respiratory parameters in ALS patients

  1 week, 6 months, 12 months

• Long-term compliance with the use of nocturnal ventilation on IVAPS vs. BiST in ALS patients

  1,6,12 months

Study Arms (2)

IVAPS mode of non-invasive ventilation

EXPERIMENTAL

Patients with ALS randomized to this arm will be treated with non-invasive home ventilation using the Intelligent Volume-Assured Pressure Support (IVAPS) mode

Device: Non-invasive home ventilation

BIST mode of non-invasive ventilation

ACTIVE COMPARATOR

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

Device: Non-invasive home ventilation

Interventions

Non-invasive home ventilation DEVICE

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.

Also known as: Resmed Stellar 150

BIST mode of non-invasive ventilation; IVAPS mode of non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The lack of eligibility for home ventilation, as per the document mentioned above
• Active cancer

Sponsors & Collaborators

• Marta Kaminska: lead
• ResMed: collaborator

Study Sites (1)

Montreal Chest Institute

Montreal, Quebec, H2W2E6, Canada

Location

Related Publications (6)

• Radunovic A, Mitsumoto H, Leigh PN. Clinical care of patients with amyotrophic lateral sclerosis. Lancet Neurol. 2007 Oct;6(10):913-25. doi: 10.1016/S1474-4422(07)70244-2.

  PMID: 17884681 BACKGROUND

• Piper AJ, Sullivan CE. Effects of long-term nocturnal nasal ventilation on spontaneous breathing during sleep in neuromuscular and chest wall disorders. Eur Respir J. 1996 Jul;9(7):1515-22. doi: 10.1183/09031936.96.09071515.

  PMID: 8836668 BACKGROUND

• Aboussouan LS, Khan SU, Meeker DP, Stelmach K, Mitsumoto H. Effect of noninvasive positive-pressure ventilation on survival in amyotrophic lateral sclerosis. Ann Intern Med. 1997 Sep 15;127(6):450-3. doi: 10.7326/0003-4819-127-6-199709150-00006.

  PMID: 9313002 BACKGROUND

• Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luis ML. Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26. doi: 10.1016/0022-510x(95)00052-4.

  PMID: 7595610 BACKGROUND

• McKim DA, Road J, Avendano M, Abdool S, Cote F, Duguid N, Fraser J, Maltais F, Morrison DL, O'Connell C, Petrof BJ, Rimmer K, Skomro R; Canadian Thoracic Society Home Mechanical Ventilation Committee. Home mechanical ventilation: a Canadian Thoracic Society clinical practice guideline. Can Respir J. 2011 Jul-Aug;18(4):197-215. doi: 10.1155/2011/139769.

  PMID: 22059178 BACKGROUND

• Atkeson AD, RoyChoudhury A, Harrington-Moroney G, Shah B, Mitsumoto H, Basner RC. Patient-ventilator asynchrony with nocturnal noninvasive ventilation in ALS. Neurology. 2011 Aug 9;77(6):549-55. doi: 10.1212/WNL.0b013e318228c0fb. Epub 2011 Jul 27.

  PMID: 21795658 BACKGROUND

Related Links

• Quebec Home Ventilation Program

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 10, 2012
• Study Start: February 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (1)