Comparing a New Breathing Mask in Severe COPD Flare-Ups
Tests a new mask during breathing support in adults with severe COPD flare-ups.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- U.O Pneumologia e Terapia Intensiva Respiratora, IRCCS AOU di BolognaBologna, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Trial code
- NCT07081776
- Record updated
- 23 July 2025
- Original description
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).Read full original descriptionShow less
Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe Exacerbation of COPD Requiring Non-Invasive Mechanical Ventilation: A Single-Center, Exploratory, Randomized Cross-Over Study
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).
Inclusion: 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.
Exclusion: Previous esophageal surgery, known esophageal stenosis, or any other condition that could put the patient at risk during the placement of the respiratory mechanics probe; Obstructive sleep apnea syndrome; Neuromuscular diseases or chest wall pathologies; Cognitive disorders that may interfere with adherence to treatments; Patients with active and unstable coronary artery disease; BMI ≥ 30 kg/m²; Need for intubation and invasive mechanical ventilation during exacerbation; Use of home non-invasive mechanical ventilation or CPAP; Contraindications for NIV.