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

NCT01746381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-21

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • ResMed

    collaborator INDUSTRY

  • Marta Kaminska

    lead OTHER

Principal Investigators

  • Marta Kaminska, MD,MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Rita Troini, RRT,MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746381 on ClinicalTrials.gov