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Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

RecruitingNAAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT06483984 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Noninvasive ventilation
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Where

2 sites
General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
Roma, Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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