Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation

This single-center, crossover study aims to investigate the effects of the new OptiNIV oronasal mask used during NIV in COPD patients with respiratory acidosis following an exacerbation. The goal is to evaluate whether the clinical benefits, in terms of reducing PaCO2 levels, are greater with the new mask compared to a traditional one (Visairo Mask).

NCT Number	NCT07081776
Lead Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna Collaborators: University of Bologna, Fisher and Paykel Healthcare
Conditions	COPD, Respiratory Acidosis
Enrollment	21 participants
Start Date	2025-08
Primary Completion	2026-10 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-07-23