European Home Mechanical Ventilation Registry

Pulmonary Disease, Chronic Obstructive Clinical Trial

— EHMVR  

Official title:

European Home Mechanical Ventilation Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02315339
• Other study ID #: CTC11633
• Status: Terminated
• Start date: August 2014
• Est. completion date: January 2019

Study information

• Verified date: April 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Congenital Central Hypoventilation Syndrome
• Duchenne Muscular Dystrophy
• Hypoventilation
• Kyphoscoliosis
• Motor Neuron Disease
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Myopathies
• Myotonic Dystrophy
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive
• Spinal Cord Injuries
• Spinal Cord Injury
• Syndrome

Locations

Country	Name	City	State
Germany	Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH	Cologne

Sponsors (3)

Lead Sponsor	Collaborator
ResMed	Clinical Trial Center North Hamburg Germany, The Clinical Research Institute Munich Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the mortality rate and the number of hospital readmissions		every year (2014 to 2019), up to 5 years
Secondary	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