Nasal high-flow compared to non-invasive ventilation in treatmentof acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease – a randomized controlled noninferiority trial (ELVIS)

Background: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a major negative impact on health status, rates of hospitalization, readmission, disease progression and mortality. Non-invasive ventilation (NIV) is the standard therapy for hypercapnic acidotic respiratory failure in AECOPD. Despite its beneficial effects, NIV is often poorly tolerated (11-34% failure rate). An increasing number of studies have documented a beneficial effect of nasal high-flow (NHF) in acute hypercapnia. We designed a prospective, randomized, multi-centre, open label, non-inferiority trial to compare treatment failure in nasal NHF vs NIV in patients with acidotic hypercapnic AECOPD. Methods: The study was conducted in about 35 sites in Germany. Patients with hypercapnic AECOPD with respiratory acidosis (pH