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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient | Active Comparator | Outpatient initiation of non-invasive mechanical ventilation |
|
| Hospitalization | Placebo Comparator | Initiation of non-invasive mechanical ventilation during hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient | Other | Outpatient Initiation of noninvasive mechanical ventilation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient satisfaction with the proces in relation to the start of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia, Pain and REspiratory Support | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41978444 | Derived | Stokholm JB, Kuchen SHL, Moller K, Gatke MR, Svenstrup K, Staehr-Rye AK. Outpatient versus inpatient initiation of home mechanical ventilation in patients with amyotrophic lateral sclerosis - a protocol for a randomised trial. Dan Med J. 2026 Mar 19;73(4):A09250733. doi: 10.61409/A09250733. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D006760 | Hospitalization |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Hospitalization |
| Other |
Initiation of non-invasive mechanical ventilation during hospitalization |
|
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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |