ALS, Chronic Respiratory Failure, Ventilation Therapy
Conditions
Brief summary
This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.
Interventions
OTHERNIV initiation in patients with ALS
NIV initiation according to standard care
Sponsors
Tampere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* ALS diagnosed by a neurology and * chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS
Exclusion criteria
* impaired cognition to give informed consent to participation * contraindication to NIV therapy * another severe disease with a prognosis of less than one year * ventilation via an artificial airway, tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIV usage hours according to different initiation locations in patients with ALS | 5 years | NIV daily usage hours in the 3-month control after initiation (determined over the preceding month) |
| Compliance with NIV according to NIV initiation setting in patients with ALS | 5 years | Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day. |
| Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation. | 5 years | The effectiveness of the treatment on the reduction of blood carbon dioxide pressure |
Countries
Finland
Outcome results
None listed