Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency (InNIVALS)

Tampere University

Status: Enrolling

Conditions: Chronic Respiratory Failure; ALS; Ventilation Therapy

Treatments: Other: NIV initiation in patients with ALS

Study type: Interventional

Funder types: Other

Identifiers

NCT06286917

R24001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

NIV initiation in outpatient clinic in patients with ALS

Active Comparator group

Description:

Starting the NIV at the outpatient clinic

Treatment:

Other: NIV initiation in patients with ALS

NIV initiation in pulmonary ward in patients with ALS

Active Comparator group

Description:

Starting the NIV in the pulmonary ward

Treatment:

Other: NIV initiation in patients with ALS