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NCT02811588Completed

HomeVent ( Connect) Registry: EU COPD Home NIV Registry

Registry of Stable Hypercapnic Chronic Obstructive Pulmonary Disease Treated With Non-Invasive Ventilation Amendment: Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

The prevalence of chronic respiratory disease, including chronic obstructive pulmonary disease (COPD), is increasing in industrialized countries. Over the next decade deaths from COPD are projected to increase by more than 30% and COPD will become the third leading cause of death worldwide by 2030. There is robust scientific evidence that non-invasive ventilation (NIV) therapy is an effective option for most COPD patients hospitalized with acute hypercapnic respiratory failure secondary to an acute disease exacerbation. More recently, NIV has been shown to significantly improve survival and quality of life in COPD patients with chronic stable hypercapnic disease. These data represent an important advance in the field, and indicate that usage of NIV in patients with chronic stable hypercapnic COPD should increase. Such an increase would be expected to improve patient outcomes and have a beneficial impact on the significant healthcare burden incurred by these patients. However, the proportion of stable COPD patients with chronic hypercapnia is unknown. In addition, using NIV at home to treat COPD patients with hypercapnic (type 2) respiratory failure has not often been considered previously and there is a paucity of data regarding NIV usage patterns over time in this setting. Phase2: There is robust scientific evidence that non-invasive ventilation (NIV) therapy is an effective option for most COPD patients hospitalised with acute hypercapnic respiratory failure secondary to an acute disease exacerbation \[3\]. More recently, NIV has been shown to significantly improve survival and quality of life in COPD patients with chronic stable hypercapnic disease \[4\] and in patients with persistent hypercapnia after an acute chronic respiratory failure \[11\]. Over the past two decades, the utilisation of NIV has become one of the most important developments in the field of mechanical ventilation. However, unsuccessful NIV was found to be independently associated with death \[5\] and poor NIV compliance was associated with higher risk of repeat acute NIV use \[6\]. There is a paucity of useful predictors of poor patient compliance and the performance of conventional algorithms for detecting COPD exacerbations is still weak. Detection of NIV failure is crucial in patient management in view of its negative effect on quality of life and prognosis and the fact that it often leads to hospitalisation. In addition, 70% of COPD-related healthcare costs are consequences of emergency and hospital stays for the treatment of exacerbations \[7\]. Recently, tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD. The incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in several European countries needs evaluation. In addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring

Status (registry)
Completed
Study type
Observational
Enrollment
169 (actual)
First submitted
9 Jun 2016
Start date
Jul 2016
Primary completion date
Dec 2024
Lead sponsor
ResMed
Diseases
COPD
NCT number
NCT02811588

What you commit to

  • Study type: Observational
  • Participants enrolled: 169
  • From Jul 2016 to the primary completion date, Dec 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Phase1:Inclusion Criteria:
  • Age ≥18 years
  • GOLD stage 3 or 4 COPD
  • pCO2 value available not older than one month
  • Ability to fully understand the study information and willing to give informed consent
    • Phase2:
    • Age ≥18 years COPD eligible for NIV treatment (according to applicable medical guidelines and local policy in routine clinical care) Prescription of an adequate ResMed NIV device with tele-monitoring option (according to Annex 1, 3.) as part of routine clinical care Acceptance of tele-monitoring and corresponding data handling Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.
    • Phase1:Exclusion Criteria:Existing treatment with NIV Phase2:Exclusion Criteria Invasive ventilation therapy Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer) Further exclusion criteria according to IFU of the device intended and prescribed

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Aachen
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AachenGermanyUnknown status
Kliniken der Stadt Köln
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CologneGermanyUnknown status
Clemenshospital
Coordinator of this site? Confirm its status
MünsterGermanyUnknown status
Marienkrankenhaus gGmbH
Coordinator of this site? Confirm its status
SoestGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.