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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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

21 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

University of Bologna

Collaborator

Fisher and Paykel Healthcare

Collaborator