European Home Mechanical Ventilation Registry

NCT02315339 | Terminated

• 1 other identifier: CTC11633
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Determine the mortality rate and the number of hospital readmissions

  every year (2014 to 2019), up to 5 years

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead
• Clinical Trial Center North Hamburg Germany: collaborator
• CRI-The Clinical Research Institute GmbH: collaborator

Study Sites (1)

Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH

Cologne, 51109, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Muscular Dystrophies; Obesity Hypoventilation Syndrome; Congenital central hypoventilation syndrome; Muscular Dystrophy, Duchenne; Muscular Diseases; Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Disorders, Atrophic; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Genetic Diseases, X-Linked; Myotonic Disorders; Heredodegenerative Disorders, Nervous System

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: December 11, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

DE (1)