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Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure

RecruitingNAAges 18 Years - anyAllUniversity of Milan
NCT07638293 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

High-flow nasal cannula (HFNC) is a widely used noninvasive respiratory support technique for patients with acute respiratory failure (ARF). It provides heated and humidified oxygen at high flow rates, improving oxygenation, reducing respiratory effort, and enhancing patient comfort. International guidelines recommend HFNC over conventional oxygen therapy in hypoxemic ARF. However, there is significant variability in clinical practice regarding HFNC discontinuation, and no standardized weaning criteria currently exist. Prolonged HFNC use may increase hospital stay and healthcare costs, while premature discontinuation may lead to respiratory deterioration and the need for further ventilatory support. Previous studies suggest that successful HFNC weaning may be predicted by a Fraction of inspired oxygen (FiO₂) ≤40% and a Respiratory rate-Oxygenation index (ROX index) ≥9.2. The ROX index is

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Presence of acute respiratory failure (ARF) * Receiving HFNC treatment for ≥24 hours Exclusion Criteria: * Post-extubation HFNC use or tracheostomized patients * Respiratory acidosis (pH \<7.35) or clinically significant acute hypercapnia (pCO₂ \>50 mmHg with worsening from baseline) * Long-term home NIV or home CPAP use * Do-not-intubate (DNI) orders precluding escalation to invasive mechanical ventilation * Life expectancy ≤48-72 hours due to terminal non-respiratory disease * Neurological impairment or deep sedation preventing safe HFNC use (e.g. coma or severe uncontrolled delirium) * Technical contraindications to HFNC (i.e. facial trauma, maxillofacial surgery, severe nasal obstruction) * Refusal to participate or inability to provide informed consent
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What it tests

  • Protocolized HFNC weaning
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Where

2 sites
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
Milan, Italy
Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
Catania, 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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