Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Hospitalization; Other: Outpatient

• Registration Number: NCT05829330
• Lead Sponsor: Anne Kathrine Staehr-Rye

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-09-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospitalization	Hospitalization	Initiation of non-invasive mechanical ventilation during hospitalization
Outpatient	Outpatient	Outpatient initiation of non-invasive mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Use of non-invasive mechanical ventilation	The 83th to the 90th day after initiation of non-invasive mechanical ventilation	Use of non-invasive mechanical ventilation in minutes per day

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the treatment	Measured at the 3 months follow-up visit	Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)
Patient satisfaction with the proces in relation to the start of the treatment	Measured at the 3 months follow-up visit	Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)

Trial Locations

Locations (1)

Department of Anaesthesia, Pain and REspiratory Support; 🇩🇰 GLostrup, Denmark