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European Home Mechanical Ventilation Registry (EHMVR)

This study has been terminated.
Sponsor:
Collaborators:
Clinical Trial Center North Hamburg Germany
The Clinical Research Institute Munich Germany
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT02315339
First received: October 6, 2014
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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.

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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: European Home Mechanical Ventilation Registry

Resource links provided by NLM:


Further study details as provided by ResMed:

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

Secondary Outcome 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 ]

Enrollment: 37
Study Start Date: August 2014
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry will target all adult individuals who have an indication for HMV (including those with amyotrophic lateral sclerosis [ALS], central hypoventilation syndrome [CHS], chronic obstructive pulmonary disease [COPD], kyphoscoliosis, obesity hypoventilation syndrome [OHS], spinal cord injury [SCI], Duchenne muscular dystrophy [DMD], muscular dystrophies [MDs] other than DMD, myopathies and myotonic dystrophy [Steinert's muscular dystrophy; SMD]). All newly-diagnosed patients with chronic respiratory diseases who are eligible for HMV treatment as part of routine care can be included in the registry. Patients who satisfy all the inclusion criteria will be consecutively enrolled into the registry.
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02315339

Locations
Germany
Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH
Cologne, Germany, 51109
Sponsors and Collaborators
ResMed
Clinical Trial Center North Hamburg Germany
The Clinical Research Institute Munich Germany
Investigators
Principal Investigator: Jean-Louis Pepin, Pr Laboratoire d'EFCR, RDC Haut Chartreuse, CHU Michallon 38043,Grenoble, France
Principal Investigator: Stefano Nava, Pr Pneumologia e Terapia Intensiva Respiratoria Ospedale Sant' Orsola Malpighi, Italy
Principal Investigator: Anita Simonds, Pr NIHR Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, United Kingdom
Principal Investigator: Wolfram Windisch, Pr Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH, Ostmerheimer Strasse 200, Germany
  More Information

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02315339     History of Changes
Other Study ID Numbers: CTC11633
Study First Received: October 6, 2014
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Myotonic Dystrophy
Myotonic Disorders
Syndrome
Lung Diseases
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Obesity Hypoventilation Syndrome
Hypoventilation
Sleep Apnea, Central
Disease
Pathologic Processes
Respiratory Tract Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 25, 2017