Pulmonary Disease, Chronic Obstructive Clinical Trial
— EHMVROfficial title:
European Home Mechanical Ventilation Registry
NCT number | NCT02315339 |
Other study ID # | CTC11633 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | January 2019 |
Verified date | April 2020 |
Source | ResMed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 37 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients aged =18 years with an indication to receive HMV as part of routine clinical care - Patient is able to fully understand the study information and is willing to give informed consent - Patient, or the patient's legal guardian, signing the consent form Exclusion Criteria: - No exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire |
Country | Name | City | State |
---|---|---|---|
Germany | Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH | Cologne |
Lead Sponsor | Collaborator |
---|---|
ResMed | Clinical Trial Center North Hamburg Germany, The Clinical Research Institute Munich Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the mortality rate and the number of hospital readmissions | every year (2014 to 2019), up to 5 years | ||
Secondary | 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 | every year (2014 to 2019), up to 5 years |
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