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Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

Inclusion Criteria:

Acute respiratory failure with

  • PaCO2 ≥ 45 mmHg;
  • Arterial pH < 7.35;
  • Signed written informed consent

Exclusion Criteria:

  • 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.

Study details
    Respiratory Insufficiency

NCT06483984

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

16 October 2025

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