Invasive Home Ventilation in Denmark

NCT07467187 | Recruiting

• 1 other identifier: p-2025-20512
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Diseases (NMD); ALS (Amyotrophic Lateral Sclerosis); Spinal Cord Injuries (SCI); Duchenne Muscular Dystrophy (DMD); SMA - Spinal Muscular Atrophy; MSA - Multiple System Atrophy; Tracheostomized Patients; Tracheostomy

Outcome Measures

Primary Outcomes (1)

• Incidence of patients with invasive home mechanical ventilation

  Incidence of patients with invasive home mechanical ventilation per year per 100,000 population

  Each year during the periode from 01.01.2016 to 12.31.2025

Secondary Outcomes (3)

• Prevalence of patients on home mechanical ventilation pr. year

  Each year during the periode from 01.01.2016 to 12.31.2025

• Number of new patients on invasive home mechanical ventilation per year

  Each year during the periode from 01.01.2016 to 12.31.2025

• One-year mortality

  Periode from 01.01.2016 to 12.31.2025

Study Arms (1)

Invasive mechanical ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Denmark with a respiratory certified personale care assistent who are fully or partially dependent on invasive ventilation during the period 2016-2025.

You may qualify if:

• Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: collaborator
• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Respiratory Center East

Copenhagen, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal; Shy-Drager Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Janne B Stokholm, M.D.

CONTACT

+45 38632376; janne.boegh.stokholm.01@regionh.dk

Anne-Katrine Staehr-Rye

CONTACT

+45 24455276; anne.kathrine.staehr.rye@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-03

Locations

DK (1)