Use of invasive home ventilation in Denmark
The Evolution of Invasive Home Mechanical Ventilation in Denmark
This project will see how often people with neuromuscular diseases or spinal cord injuries in Denmark used invasive home mechanical ventilation between 2016 and 2025 and what their one-year outcomes were.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07467187 on ClinicalTrials.gov |
What this trial studies
This is a national retrospective observational cohort using hospital records and registries from 1 January 2016 to 31 December 2025. The study will identify tracheostomized patients who received invasive home mechanical ventilation and who had respiratory-certified personal care assistants, and will categorize indications and diagnostic groups (ALS, SMA, DMD, other neuromuscular diseases, and spinal cord injuries). Primary outputs are national trends in invasive HMV use and one-year mortality after initiation, with descriptive data on discharge setting and breathing status. Data collection is led by Rigshospitalet with collaborating centers at Aarhus University Hospital and Odense University Hospital; no interventional treatments are given.
Who should consider this trial
Good fit: Ideal candidates are people in Denmark with neuromuscular disease or spinal cord injury who were tracheostomized and received invasive home mechanical ventilation with a respiratory-certified personal care assistant between 2016 and 2025.
Not a fit: People who were never tracheostomized, who remained on spontaneous breathing during 2016–2025, or who were not discharged to home, assisted living, nursing home, or rehabilitation are not included and would not benefit from participation.
Why it matters
Potential benefit: If successful, this work could help clinicians and health planners target resources and timing of ventilation support for high-risk groups to reduce early mortality.
How similar studies have performed: Registry and cohort studies from other countries have described trends and outcomes for home mechanical ventilation, so the approach is established though Denmark-specific invasive HMV data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025. Exclusion Criteria: * Not tracheostomized * Tracheostomized but on spontaneous breathing throughout 1 January 2016 - 31 December 2025 * Not discharged to home, assisted living, nursing home, or rehabilitation during 1 January 2016 - 31 December 2025
Where this trial is running
Copenhagen
- Respiratory Center East — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Janne B Stokholm, M.D.
- Email: janne.boegh.stokholm.01@regionh.dk
- Phone: +45 38632376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.