Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Recruiting now · Not applicable

Conditions studied: Respiratory Insufficiency

In brief

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

Key facts

Study ID

NCT06483984

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

20

Starts

2024-11-15

Expected to finish

2026-10-01

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute respiratory failure with
• PaCO2 ≥ 45 mmHg;
• Arterial pH < 7.35;
• Signed written informed consent

You may not qualify if…

• 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.

Where it is running

• General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS — Roma, Italy (enrolling)
• Fondazione Policlinico Universitaro A. Gemelli IRCCS — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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