Actively Recruiting
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-30
20
Participants Needed
2
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
CONDITIONS
Official Title
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute respiratory failure with PaCO2 63 45 mmHg
- Arterial pH < 7.35
- Signed written informed consent
You will not qualify if you...
- Respiratory rate < 12 breaths per minute
- Immediate need for intubation
- Hemodynamic instability (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock
- Metabolic acidosis
- Recent head surgery or anatomy preventing facemask application
- Contraindications to oesophageal balloon insertion and/or electrical impedance tomography belt placement
- Contraindications to facemask noninvasive ventilation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
Roma, Italy
Actively Recruiting
2
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
Actively Recruiting
Research Team
D
Domenico Luca Grieco, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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