Home initiation of chronic high-intensity noninvasive ventilation in COPD patients with chronic hypercapnic respiratory failure: the RECONSIDER trial

Abstract

Background: Chronic high-intensity noninvasive ventilation (NIV) has become evidence based care for stable hypercapnic chronic obstructive pulmonary disease (COPD) patients. Since the number of patients is increasing, home initiation of NIV would greatly alleviate the healthcare burden.

Hypothesis: Home initiation of chronic high-intensity NIV in stable hypercapnic COPD is non-inferior to in-hospital initiation.

Methods: Sixty-seven patients with stable hypercapnic COPD were randomised between standard in-hospital NIV initiation or home NIV initiation using telemedicine. The primary outcome was daytime arterial carbon dioxide pressure (PaCO₂) reduction after 6 months NIV, with a non-inferiority margin set at 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 at 6 months: 0.04 kPa (95% CI -0.3 to 0.4), with both groups showing a reduction in PaCO₂ at 6 months compared to baseline (home: from 7.3 ± 0.9 to 6.4 ± 0.8 kPa (P<0.001); in-hospital: from 7.4 ± 1.0 to 6.4 ± 0.6 kPa (P<0.001)). There was no difference in improvement in HRQoL (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. hospital: median €8537 (IQR €7540-€9175); P<0.001).

Discussion: This is the first study showing that home initiation of high-intensity NIV in stable hypercapnic COPD patients is non-inferior to to in-hospital initiation, with over 50% savings of costs.