HomeVent ( Connect) Registry: EU COPD Home NIV Registry

NCT02811588 | Active Not Recruiting

• 1 other identifier: CA5 - NIV COPD Registry EU
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Phase 1: Prevalence of hypercapnia in patients with GOLD stage 3 and 4 COPD.

  Phase1:July 2017

• Phase2:Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data

  Unplanned hospitalisation is within this protocol defined as ill-defined hospital admissions in acute inpatient medical settings for any cause for more than one calendar day (overnight stay) where managing demand for unplanned admissions is a priority \[13\].

  Dec20-Dec22

Secondary Outcomes (5)

• Patterns of NIV use

  July 2017

• Phase2:Incidence of unplanned COPD-caused hospitalisations

  Dec20-Dec22

• Phase2:Predictors of unplanned all-cause hospitalisations

  Dec20-Dec22

• Phase2:Predictors of unplanned COPD-caused hospitalisations

  Dec20-Dec22

• Phase2:Predictors of compliance and persistence to NIV therapy

  Dec20-Dec22

Study Arms (4)

Phase1:Screening phase: normocapnic group

Normocapnic COPD patients

Phase1;Screening phase: hypercapnic group

Hypercapnic COPD patients

Phase1:Treatment phase: control group

Hypercapnic COPD patients in whom NIV is not indicated or who have contraindication(s) for, or refuse, NIV treatment.

Phase1:Treatment phase: non-invasive ventilation group

Hypercapnic COPD patients in whom NIV is indicated and who accept NIV treatment.

Device: Non-invasive ventilation

Interventions

Non-invasive ventilation DEVICE

Phase1:Treatment phase: non-invasive ventilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 550 adult female and male patients with COPD eligible for NIV treatment will be enrolled, out of which 231 patients have been enrolled within the phase 1 of the study. If a patient is enrolled into the study but is never using the prescribed device (i.e. refusal of prescribed therapy) he/she will be replaced. If a patient, who has already started NIV therapy, is enrolled, the start of therapy must not be longer than 7 days before enrolment. Within this study population, data of a maximum of about 100 patients will be added by the French ANTADIR registry in line with in- and exclusion criteria of this observational study.

You may qualify if:

• 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.

Sponsors & Collaborators

• ResMed: lead
• CRI-The Clinical Research Institute GmbH: collaborator

Study Sites (4)

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Clemenshospital

Münster, Westfalen Lippe, 48153, Germany

Location

Marienkrankenhaus gGmbH

Soest, Westfalen Lippe, 59494, Germany

Location

Kliniken der Stadt Köln

Cologne, 51109, Germany

Location

Related Publications (3)

• Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007 Sep 1;370(9589):765-73. doi: 10.1016/S0140-6736(07)61380-4.

  PMID: 17765526 BACKGROUND

• Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22. doi: 10.1056/NEJM199509283331301.

  PMID: 7651472 BACKGROUND

• Dreher M, Neuzeret PC, Windisch W, Martens D, Hoheisel G, Groschel A, Woehrle H, Fetsch T, Graml A, Kohnlein T. Prevalence Of Chronic Hypercapnia In Severe Chronic Obstructive Pulmonary Disease: Data From The HOmeVent Registry. Int J Chron Obstruct Pulmon Dis. 2019 Oct 18;14:2377-2384. doi: 10.2147/COPD.S222803. eCollection 2019.

  PMID: 31695357 RESULT

Related Links

• Global Initiative for Chronic Obstructive Lung Disease webpage

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Michael Dreher, Prof

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

• Nicholas Hart, Prof

  NHS Foundation

  STUDY CHAIR

• Claudio Rabec, Prof

  Centre Hospitalier et Universitaire Dijon

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)