European Home Mechanical Ventilation Registry (EHMVR)

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 Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Duchenne Muscular Dystrophy; Myotonic Dystrophy; Spinal Cord Injury; Obesity Hypoventilation Syndrome; Kyphoscoliosis; Congenital Central Hypoventilation Syndrome; Myopathies

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
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 51109
    • Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Clinical Trial Center North Hamburg Germany; CRI-The Clinical Research Institute GmbH
• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Wounds and Injuries; Disease; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Trauma, Nervous System; Signs and Symptoms, Respiratory; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Lung Diseases, Obstructive; Sleep Apnea Syndromes; Muscular Disorders, Atrophic; Heredodegenerative Disorders, Nervous System; Respiratory Insufficiency; Obesity; Myotonic Disorders; Sleep Apnea, Obstructive; Syndrome; Pulmonary Disease, Chronic Obstructive; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Spinal Cord Injuries; Muscular Dystrophy, Duchenne; Myotonic Dystrophy; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: CTC11633

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No