welcome to DuchenneXchange- a positively charged Duchenne muscular dystrophy community.
- join today!
- log in
European Home Mechanical Ventilation Registry
study id #: NCT02315339
condition: 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
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.
mechanism of action: No pharmaceutical intervention
last updated: April 19, 2020
start date: August 2014
estimated completion: January 2019
size / enrollment: 37
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).
- Determine the mortality rate and the number of hospital readmissions. [Time Frame: every year (2014 to 2019), up to 5 years]
- 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]
• 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
No exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire.
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular DystrophyThis study is being performed as a post-...
Impact of invasive ventilation on survival when non-invasive ventilation is ineffective in patients with Duchenne mu...Background: Many patients with DMD unde...
Optimum Insufflation Capacity in NMDPatients with underlying neuromuscular d...
The Duchenne RegistryThe Duchenne Registry is an online, pati...
DMD HUB: Expanding clinical trial capacity for Duchenne muscular dystrophy in the UKWith Duchenne muscular dystrophy (DMD) c...
Duchenne Pulmonary Awareness: C-PAP/BiPAPhttps://www.youtube.com/watch?v=_EuyErNY...
Respiratory management of the patient with Duchenne muscular dystrophyIn 2010, Care Considerations for Duchenn...
PTC Therapeutics Celebrates the Fifth Anniversary of STRIVE Grant Awards by Announcing 2019 Award WinnersSOUTH PLAINFIELD, N.J., Sept. 6, 2019 ...