NCT02315339

European Home Mechanical Ventilation Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation of HMV by documenting the characteristics of HMV patients and their treatment. This will facilitate a prospective, observational study to identify the primary indications for HMV, describe patterns of HMV use in European countries, and characterize changes in the initiation and utilization of HMV over time. The registry will target all adult individuals who have an indication for HMV. In the EHMVR, patient data from routine clinical care will be documented using an electronic case report form (eCRF). The eCRF will record: patient demographic data; diagnostic information (including primary diagnosis, 6-minute walk time, the presence of depression, and quality of life); blood gases; ventilation treatment (including type of ventilator, modes and settings, interfaces used); follow-up data (including failure rates, side effects, technical issues). An initial Pilot Phase will be launched with the aim to enrol at least 200 patients over a 6-month period to determine the feasibility of the registry. Steering committee members and their institutions will be the main participants in the Pilot Phase. After completion of the Pilot Phase, the registry will be expanded across Europe with the goal of enrolling approximately 10,000 patients over 5 years.

Detailed description

The data (baseline and follow-up) should be collected as part of routine clinical care. In clinical practice, after HMV initiation, the first control examination (follow-up number one) with nocturnal diagnostics should take place within the first 4-8 weeks. Annual follow-up is required, and it is recommended that subsequent control visits should be performed 1-2 times a year. Each patient will be included for 5 years (total duration of the registry).

Conditions

• Pulmonary Disease, Chronic Obstructive
• Amyotrophic Lateral Sclerosis
• Spinal Cord Injury
• Muscular Dystrophies
• Obesity Hypoventilation Syndrome
• Kyphoscoliosis
• Congenital Central Hypoventilation Syndrome
• Duchenne Muscular Dystrophy
• Myopathies
• Myotonic Dystrophy

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2014-12-11
• Last updated: 2020-04-09

Locations

1 site across 1 country: Germany