Clinical Trial: European Home Mechanical Ventilation Registry

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational [Patient Registry]

Official Title: European Home Mechanical Ventilation Registry

Brief 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 Summary: 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).
Sponsor: ResMed

Current Primary Outcome: Determine the mortality rate and the number of hospital readmissions [ Time Frame: every year (2014 to 2019), up to 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the effects of home mechanical ventilation on health-related quality of life using the EQ-5D and the Severe Respiratory Insufficiency questionnaires quality of life [ Time Frame: every year (2014 to 2019), up to 5 years ]

Original Secondary Outcome: Same as current

Information By: ResMed

Dates:
Date Received: October 6, 2014
Date Started: August 2014
Date Completion: August 2019
Last Updated: October 25, 2016
Last Verified: October 2016