European Home Mechanical Ventilation Registry

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Brief Title

European Home Mechanical Ventilation 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 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).
    


Study Type

Observational [Patient Registry]


Primary Outcome

Determine the mortality rate and the number of hospital readmissions

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

Condition

Pulmonary Disease, Chronic Obstructive



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

37

Start Date

August 2014

Completion Date

January 2019

Primary Completion Date

January 2019

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Louis Pepin, Pr, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02315339

Organization ID

CTC11633


Responsible Party

Sponsor

Study Sponsor

ResMed

Collaborators

 Clinical Trial Center North Hamburg Germany

Study Sponsor

Jean-Louis Pepin, Pr, Principal Investigator, Laboratoire d'EFCR, RDC Haut Chartreuse, CHU Michallon 38043,Grenoble, France


Verification Date

April 2020