European Home Mechanical Ventilation Registry

Overview

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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2019

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).

Clinical Trial Outcome Measures

Primary Measures

  • Determine the mortality rate and the number of hospital readmissions
    • Time Frame: every year (2014 to 2019), up to 5 years

Secondary Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Collaborator
    • Clinical Trial Center North Hamburg Germany
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Louis Pepin, Pr, Principal Investigator, Laboratoire d’EFCR, RDC Haut Chartreuse, CHU Michallon 38043,Grenoble, France
    • Stefano Nava, Pr, Principal Investigator, Pneumologia e Terapia Intensiva Respiratoria Ospedale Sant’ Orsola Malpighi, Italy
    • Anita Simonds, Pr, Principal Investigator, NIHR Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, United Kingdom
    • Wolfram Windisch, Pr, Principal Investigator, Lungen Klinik – Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH, Ostmerheimer Strasse 200, Germany

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