ClinicalTrials.gov record NCT07467187
Invasive Home Ventilation in Denmark
The Evolution of Invasive Home Mechanical Ventilation in Denmark
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective observational study describes national trends from 2016–2025 in people receiving invasive home mechanical ventilation in Denmark. It looks at indications and diagnostic groups, annual incidence and prevalence, number of new patients each year, and one-year mortality. The study identifies people who were fully or partially dependent on invasive ventilation and who had a respiratory certified personale care assistent during 2016–2025.
What it is studying. The study aims to describe how use of invasive home mechanical ventilation in Denmark changed from 2016 to 2025: who received it, why (indications/diagnoses), year-by-year counts and rates, and one-year mortality after starting invasive HMV.
What the researchers hope to learn. To map national trends in invasive home mechanical ventilation in Denmark over 2016–2025, including indications and diagnostic groups; to report annual incidence per 100,000, annual prevalence, numbers of new patients per year, and one-year mortality after starting invasive HMV.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective observational study: investigators will use existing clinical/care records from 2016–2025 to describe invasive home mechanical ventilation (incidence, prevalence, new starts) and one-year mortality. Participants are not assigned any study treatments. The registry does not provide details about additional contact, interviews, or new tests for participants.
How the study is structured. A retrospective, case-only observational review of records from 2016–2025. Researchers will count annual incidence per 100,000 population, annual prevalence, the absolute number of new patients starting invasive home mechanical ventilation each year, and one-year mortality after initiation.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Denmark. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Apr 13, 2026
- Primary completion
- Sep 1, 2028 (estimated)
- Study completion
- Sep 1, 2028 (estimated)
- Target enrollment
- 450 participants (estimated)
- Last updated on registry
- Apr 20, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Rigshospitalet, Denmark
- Principal investigator
- Janne B Stokholm, Principal Investigator
Rigshospitalet, Denmark - Collaborators
- Aarhus University Hospital
- Odense University Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Janne B Stokholm, M.D. 📞 +45 38632376 ✉ janne.boegh.stokholm.01@regionh.dk
- Anne-Katrine Staehr-Rye 📞 +45 24455276 ✉ anne.kathrine.staehr.rye@regionh.dk
Participating sites (1)
- Respiratory Center EastRecruiting
Copenhagen, 2600 · Denmark
- Janne B Stokholm · +45 38632376 · janne.boegh.stokholm.01@regionh.dk
- Anne-Katrine Staehr-Rye · +45 24455276 · anne.kathrine.staehr.rye@regionh.dk
- Janne B Stokholm
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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