Late Breaking Abstract - Outpatient follow-up of COPD patients receiving long-term non-invasive ventilation (OCONIV-Trial): A randomized controlled trial

<bold>Background:</bold> Long-term non-invasive ventilation (NIV) has emerged as standard treatment for chronic hypercapnic COPD-patients over the past decade. Since patient numbers are steadily increasing, specialized outpatient settings are needed. <bold>Hypothesis:</bold> Outpatient follow-up of long-term NIV in stable hypercapnic COPD is superior over inpatient care regarding health-related quality of life (HRQL). <bold>Methods:</bold> 113 patients with stable hypercapnic COPD were randomised to standard inpatient or outpatient NIV follow-up using a predefined protocol (1:1). The primary outcome was the mean difference in HRQL assessed by the Severe Respiratory Insufficiency Questionnaire (SRI) after 12 months. Adherence, patient preference, costs and capillary blood gases served as secondary outcomes. <bold>Results:</bold> Outpatient NIV follow-up was associated with a comparable SRI Summary Score after 12 months compared to inpatient follow-up (adjusted mean difference 3.7±2.5; P=0.137)). Across all time points, the outpatient group tended to have even larger improvements in the mean SRI Summary Score (P=0.07). PaCO₂ during spontaneous breathing (47.6±10.1 vs. 46.5±6.2mmHg, P=0.906) and NIV adherence (8.3±3.5 vs. 8.5±2.3h; P=0.243) were comparable (out- versus inpatient). Costs were higher for inpatient care, while outpatient treatment were preferred by most patients (84.3%). <bold>Discussion:</bold> Outpatient NIV follow-up for COPD-patients oriented towards a predefined protocol is feasible and associated with comparable and in tendency better HRQL compared to inpatient follow-up. In addition, outpatient treatment is more cost-effective and also preferred by most of the patients and should become standard treatment.