Back to resultsAmbulatory Versus Inpatient Initiation of Home Mechanical Ventilation
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Outpatient
Hospitalization
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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
Sites / Locations
- Department of Anaesthesia, Pain and REspiratory SupportRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Outpatient
Hospitalization
Arm Description
Outpatient initiation of non-invasive mechanical ventilation
Initiation of non-invasive mechanical ventilation during hospitalization
Outcomes
Primary Outcome Measures
Use of non-invasive mechanical ventilation
Use of non-invasive mechanical ventilation in minutes per day
Secondary Outcome Measures
Patient satisfaction with the treatment
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
Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)
Full Information
NCT ID
NCT05829330
First Posted
March 15, 2023
Last Updated
September 20, 2023
Sponsor
Anne Kathrine Staehr-Rye
1. Study Identification
Unique Protocol Identification Number
NCT05829330
Brief Title
Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anne Kathrine Staehr-Rye
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Outpatient
Arm Type
Active Comparator
Arm Description
Outpatient initiation of non-invasive mechanical ventilation
Arm Title
Hospitalization
Arm Type
Placebo Comparator
Arm Description
Initiation of non-invasive mechanical ventilation during hospitalization
Intervention Type
Other
Intervention Name(s)
Outpatient
Intervention Description
Outpatient Initiation of noninvasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Hospitalization
Intervention Description
Initiation of non-invasive mechanical ventilation during hospitalization
Primary Outcome Measure Information:
Title
Use of non-invasive mechanical ventilation
Description
Use of non-invasive mechanical ventilation in minutes per day
Time Frame
The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Secondary Outcome Measure Information:
Title
Patient satisfaction with the treatment
Description
Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)
Time Frame
Measured at the 3 months follow-up visit
Title
Patient satisfaction with the proces in relation to the start of the treatment
Description
Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)
Time Frame
Measured at the 3 months follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Kathrine Staehr-Rye, MD
Phone
004538683868
Email
Anne.kathrine.staehr.rye@regionh.dk
Facility Information:
Facility Name
Department of Anaesthesia, Pain and REspiratory Support
City
GLostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Kathrine Staehr-Rye
Phone
+4528665645
Email
anne.kathrine.staehr.rye@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anne Kathrine Staehr-Rye, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation
We'll reach out to this number within 24 hrs