About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years
Informed consent obtained
Patients with COPD and acute hypoxemic-hypercapnic respiratory failure (pH < 7.35, PaO₂ < 60 mmHg, PaCO₂ > 45 mmHg) requiring non-invasive mechanical ventilation.
Disqualifiers
BMI ≥ 30 kg/m²
Obstructive sleep apnea syndrome
Neuromuscular diseases or chest wall pathologies
Need for intubation and invasive mechanical ventilation during exacerbation
Trial design
Treatments tested in this trial
- OptiNIV
- Visairo
Treatment groups
Sponsors and collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
University of Bologna
Collaborator
Fisher and Paykel Healthcare
Collaborator