Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation. The purpose is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV. Partecipants will be randomized at 1:1 ratio into two groups: group 1: will start the respiratory strategy under study (NHF + standard oxygen therapy) as first treatment group 2 will start the control respiratory strategy (HMV + standard oxygen therapy) as first treatment. The study has a crossover design: each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months

NCT Number	NCT07065799
Lead Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna Collaborators: Azienda Sanitaria dell'Alto Adige, Ospedale San Donato, Azienda Unita Sanitaria Locale di Piacenza, Policlinico Universitario, Catania, Fondazione Salvatore Maugeri
Conditions	COPD, Hypercapnia, Exacerbation Copd
Enrollment	31 participants
Start Date	2024-06-30
Primary Completion	2027-12 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-15