Status:
RECRUITING
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 hyp...
Eligibility Criteria
Inclusion
- Acute respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH \< 7.35;
- Signed written informed consent
Exclusion
- Respiratory rate \< 12 bpm;
- Immediate need for intubation;
- Haemodynamic 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 that prevent the application of facemasks;
- Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
- Any contraindications to facemask noninvasive ventilation.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06483984
Start Date
November 15 2024
End Date
October 1 2026
Last Update
September 30 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
Roma, Italy
2
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy