Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Anne Kathrine Staehr-Rye

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Hospitalization; Other: Outpatient

Study type: Interventional

Funder types: Other

Identifiers

NCT05829330

H-23005093

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Diagnosed with amyotrophic lateral sclerosis
• Indication for start of non-invasive mechanical ventilation

Exclusion criteria

• No informed consent
• Does not understand Danish or English
• Indication for invasive mechanical ventilation
• No morning baseline PCO2
• Hospitalization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

46 participants in 2 patient groups, including a placebo group

Outpatient

Active Comparator group

Description:

Outpatient initiation of non-invasive mechanical ventilation

Treatment:

Other: Outpatient

Hospitalization

Placebo Comparator group

Description:

Initiation of non-invasive mechanical ventilation during hospitalization

Treatment:

Other: Hospitalization