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Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

ConditionsVentilation TherapyALSChronic Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTampere University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ALS diagnosed by a neurology and

chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • NIV initiation in patients with ALS

    Other intervention

    NIV initiation according to standard care

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: NIV initiation in outpatient clinic in patients with ALSActive comparator 1 intervention
Group B: NIV initiation in pulmonary ward in patients with ALSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

NIV usage hours according to different initiation locations in patients with ALS

NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)

Time frame
5 years
2

Compliance with NIV according to NIV initiation setting in patients with ALS

Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.

Time frame
5 years
3

Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.

The effectiveness of the treatment on the reduction of blood carbon dioxide pressure

Time frame
5 years

Secondary outcomes

Other outcomes

1

Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS

How much does the initiation of NIV cost in outpatient setting compared with initiation in a pulmonary ward including all the contacts with a nurse and a doctor during the following year after the initiation.

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University

Lead sponsor

Tampere University Hospital

Sponsor institution

Source ClinicalTrials.gov
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