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.

中文翻译：

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慢性高碳酸血症性呼吸衰竭 COPD 患者在家启动慢性无创通气：一项随机对照试验

介绍 慢性无创通气 (NIV) 已成为稳定高碳酸血症 COPD 患者的循证护理。在患者数量增加的同时，在家启动 NIV 将大大减轻医疗负担。我们假设在稳定的高碳酸血症 COPD 中使用远程医疗在家启动 NIV 不劣于住院 NIV 启动。方法 67 名稳定的高碳酸血症 COPD 患者被随机分配到医院或家中使用远程医疗开始 NIV。主要结果是 6 个月 NIV 后白天动脉二氧化碳压力 (PaCO2) 降低，非劣效性界限为 0.4 kPa。次要结果是健康相关生活质量 (HRQoL) 和成本。不劣于院内启动，安全且成本降低50%以上。试验注册号 NCT02652559。