- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746381
Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode
Initiation of Long-term Home Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode During a Daytime Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2W2E6
- Montreal Chest Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
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.
|
1,6,12 months
|
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.
|
1 week, 6 months, 12 months
|
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.
|
1,6,12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2902
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyotrophic Lateral Sclerosis (ALS)
-
Northwestern UniversityCompletedAmyotrophic Lateral Sclerosis (ALS) | Lou Gehrig's Disease | Primary Lateral Sclerosis (PLS) | Familial Amyotrophic Lateral Sclerosis | ALS With Frontotemporal Dementia (ALS/FTD) | Motor Neuron Disease (MND) | Sporadic ALS (SALS)United States
-
Dallas VA Medical CenterRecruitingAmyotrophic Lateral Sclerosis (ALS)United States
-
St. Joseph's Hospital and Medical Center, PhoenixEmory University; Mitsubishi Tanabe Pharma America Inc.Active, not recruitingALS (Amyotrophic Lateral Sclerosis)United States
-
Taipei Veterans General Hospital, TaiwanUnknownDevelopment and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.ALS (Amyotrophic Lateral Sclerosis)Taiwan
-
Brainstorm-Cell TherapeuticsCompletedAmyotrophic Lateral Sclerosis (ALS)United States
-
Phoenix Neurological Associates, LTDInstitute for EthnomedicineUnknown
-
Skulpt, Inc.National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedAmyotrophic Lateral Sclerosis (ALS)United States
-
Neuromed IRCCSRecruitingAmyotrophic Lateral Sclerosis (ALS)Italy
-
Humanitas Mirasole SpAKU Leuven; UMC Utrecht; University of Sheffield; Istituto Superiore di Sanità; University... and other collaboratorsActive, not recruitingAmyotrophic Lateral Sclerosis (ALS)United Kingdom, Germany, France, Netherlands, Belgium, Ireland, Italy
-
The Methodist Hospital Research InstituteMassachusetts General Hospital; The Center for Clinical and Translational Sciences... and other collaboratorsActive, not recruiting
Clinical Trials on Non-invasive home ventilation
-
United Christian HospitalPhilips Respironics; The Hong Kong Lung FoundationCompletedChronic Obstructive Pulmonary Disease | Hypercapnic Respiratory FailureHong Kong
-
Guy's and St Thomas' NHS Foundation TrustCompletedMotor Neurone Disease | Hypoxemia and/or HypercapniaUnited Kingdom
-
Centre Chirurgical Marie LannelongueCentre Hospitalier René Dubos; University Hospital, Bordeaux; University Hospital... and other collaboratorsCompletedRespiratory InsufficiencyFrance
-
Hamilton Health Sciences CorporationRecruiting
-
Universidade Federal do Rio Grande do NorteCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Spaulding Rehabilitation HospitalCompletedSpinal Cord InjuryUnited States
-
University Hospital, MontpellierCompletedRespiratory Failure | Non Invasive Ventilation on Healthy VolunteerFrance
-
Sociedad Española de Neumología y Cirugía TorácicaCompletedObesity Hypoventilation Syndrome | Chronic Hypercapnic Respiratory FailureSpain
-
Postgraduate Institute of Medical Education and...Completed
-
Centre Hospitalier Intercommunal de Toulon La Seyne...Completed