Clinical trial Recruiting at 1 site Observational

Use of invasive home ventilation in Denmark

Official title: The Evolution of Invasive Home Mechanical Ventilation in Denmark

Run by Copenhagen University Hospital, Rigshospitalet · NCT07467187 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment450 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedApril 13, 2026
Main results expectedSeptember 1, 2028
Study endsSeptember 1, 2028
Registry record updatedApril 20, 2026
Trial IDNCT07467187 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Respiratory Center East
    Copenhagen, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.