Pulmonary Disease, Chronic ObstructiveEHMVRNCT02315339
European Home Mechanical Ventilation Registry
An observational study of Pulmonary Disease, Chronic Obstructive and Amyotrophic Lateral Sclerosis, run by ResMed at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis, Spinal Cord Injury
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Jan 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire
Trial locations and contacts
1 site in 1 country.
Germany1 site
Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH
Cologne, 51109
About this study
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.
Read the 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).
- Conditions
- Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis, Spinal Cord Injury, Muscular Dystrophies, Obesity Hypoventilation Syndrome, Kyphoscoliosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Muscular Dystrophies, Obesity Hypoventilation Syndrome, Congenital central hypoventilation syndrome, Muscular Dystrophy, Duchenne, Muscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the mortality rate and the number of hospital readmissions
Measured: 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
Measured: every year (2014 to 2019), up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Center North Hamburg Germany, CRI-The Clinical Research Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, Pr, Principal investigator, Laboratoire d'EFCR, RDC Haut Chartreuse, CHU Michallon 38043,Grenoble, FranceStefano Nava, Pr, Principal investigator, Pneumologia e Terapia Intensiva Respiratoria Ospedale Sant' Orsola Malpighi, ItalyAnita Simonds, Pr, Principal investigator, NIHR Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, United KingdomWolfram Windisch, Pr, Principal investigator, Lungen Klinik - Chefarzt Abt. Pneumologie Kliniken der StadtKölng GmbH, Ostmerheimer Strasse 200, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315339
- Sponsor's protocol ID
- CTC11633
- Acronym
- EHMVR
- Status last verified
- Apr 2020
- First submitted
- 6 Oct 2014
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Home Mechanical Ventilation Registry
- ClinicalTrials.gov ID
- NCT02315339
- Acronym / sponsor ID
- EHMVR / CTC11633
- Conditions
- Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis, Spinal Cord Injury, Muscular Dystrophies, Obesity Hypoventilation Syndrome, Kyphoscoliosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Center North Hamburg Germany, CRI-The Clinical Research Institute GmbH
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the mortality rate and the number of hospital readmissions
Time frame: every year (2014 to 2019), up to 5 years
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Pepin, Pr principal investigator
Laboratoire d'EFCR, RDC Haut Chartreuse, CHU Michallon 38043,Grenoble, France
Stefano Nava, Pr principal investigator
Pneumologia e Terapia Intensiva Respiratoria Ospedale Sant' Orsola Malpighi, Italy
Anita Simonds, Pr principal investigator
NIHR Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Amyotrophic Lateral Sclerosis, run by ResMed at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the mortality rate and the number of hospital readmissions (time frame: every year (2014 to 2019), up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.