NCT07081776Not yet recruiting
Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- Aug 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- COPD
- NCT number
- NCT07081776
What you commit to
- Study type: Interventional
- Planned participants: 21
- From Aug 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| U.O Pneumologia e Terapia Intensiva Respiratora, IRCCS AOU di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.