Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- NIV initiation in patients with ALS
- Conditions
- Ventilation Therapy
- Sponsor
- Tampere University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Compliance with NIV according to NIV initiation setting in patients with ALS
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Heidi Rantala
Consultant
Tampere University Hospital
Eligibility Criteria
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
Arms & Interventions
NIV initiation in outpatient clinic in patients with ALS
Starting the NIV at the outpatient clinic
Intervention: NIV initiation in patients with ALS
NIV initiation in pulmonary ward in patients with ALS
Starting the NIV in the pulmonary ward
Intervention: NIV initiation in patients with ALS
Outcomes
Primary Outcomes
Compliance with NIV according to NIV initiation setting in patients with ALS
Time Frame: 5 years
Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.
NIV usage hours according to different initiation locations in patients with ALS
Time Frame: 5 years
NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)
Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.
Time Frame: 5 years
The effectiveness of the treatment on the reduction of blood carbon dioxide pressure