Introduction Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.
Methods Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO2) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.
Results Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO2 change home vs in-hospital: 0.04 kPa (95% CI −0.31 to 0.38 kPa), with both groups showing a PaCO2 reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI −0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546–€4163) vs in-hospital: median €8537 (IQR €7540–€9175); p<0.001).
Discussion This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.
Trial registration number NCT02652559.
- non-invasive ventilation
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Presented at The study has been submitted to the European Respiratory Society Congress 2019.
Contributors MLD is the principal investigator of the project, wrote the research protocol, collected the data, performed (with help) most of the analyses and wrote the manuscript. JMV assisted with the design and statistical analyses. GB initiated the patients at home and assisted with the data collection. AH assisted with the idea and the protocol, and commented on the final manuscript. JPvM assisted in the cardiac data and the interpretation of these data. JFMvB designed the CEA and assisted in the analysis of the costs and writing of the manuscript with respect to the economic analysis. HAMK and PJW assisted in the design, study and writing of the manuscript. JN contributed substantially in the preparation and conduct of the study.
Funding The study was funded by the Dutch Lung Foundation (junior investigator grant number 5.2.15.057JO). Additional funding to facilitate the home NIV initiation was provided by the Philips Respironics, Murrysville, Pennsylvania, USA, but the company had no role in the design and conduct of the trial, nor the analyses of the results or writing of the paper.
Competing interests MLD reports a grant from the Dutch Lung Foundation (junior investigator grant number 5.2.15.057JO) and the Philips Respironics, Murrysville, Pennsylvania, USA, provided for the conduct of the present study. Furthermore, MLD received grants and personal fees from Vivisol B.V., grants from Fisher and Paykel Ltd, and personal fees from Philips, outside the submitted work. JMV, GB, AH, JN, JPvM and JFMvB have no competing interests. HAMK reports an unrestricted research grant and fees for participation in advisory boards from Boehringer Ingelheim, Novartis and GlaxoSmithKline, and fees for advisory board participation from AstraZeneca and Chiesi, all above paid to his institution and outside the submitted work. PJW reports grants and personal fees from Philips and RESMED, grants from Vital Air, VIVISOL and Goedegebuure, and personal fees from Synapse and Bresotec, all outside the submitted work.
Patient consent for publication Not required.
Ethics approval The study was approved by the Medical Ethical Board of the University Medical Center Groningen (METc 2016.031)
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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