Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Amyotrophic Lateral Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829330
• Other study ID #: H-23005093
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Rigshospitalet, Denmark
• Contact: Anne Kathrine Staehr-Rye, MD
• Phone: 004538683868
• Email: Anne.kathrine.staehr.rye[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Outpatient
Outpatient Initiation of noninvasive mechanical ventilation
• Hospitalization
Initiation of non-invasive mechanical ventilation during hospitalization

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Pain and REspiratory Support	GLostrup

Sponsors (1)

Lead Sponsor	Collaborator
Anne Kathrine Staehr-Rye

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of non-invasive mechanical ventilation	Use of non-invasive mechanical ventilation in minutes per day	The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Secondary	Patient satisfaction with the treatment	Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)	Measured at the 3 months follow-up visit
Secondary	Patient satisfaction with the proces in relation to the start of the treatment	Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)	Measured at the 3 months follow-up visit