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COMPLETED
NCT05829330
NA

Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Sponsor: Anne Kathrine Staehr-Rye

View on ClinicalTrials.gov

Summary

The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.

Official title: Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2023-09-20

Completion Date

2026-05-01

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

OTHER

Outpatient

Outpatient Initiation of noninvasive mechanical ventilation

OTHER

Hospitalization

Initiation of non-invasive mechanical ventilation during hospitalization

Locations (1)

Department of Anaesthesia, Pain and REspiratory Support

Glostrup Municipality, Denmark