Weaning HFNC: When to Stop High-Flow Oxygen in Acute Respiratory Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares a protocolized weaning approach for high-flow nasal therapy (HFNC) against standard care in adults with acute respiratory failure. It aims to reduce variability in HFNC discontinuation and identify criteria that predict safe weaning, such as FiO2 ≤ 40% and a ROX index ≥ 9.2. The protocol focuses on standardized steps to taper HFNC while monitoring for signs of deterioration. The trial will measure respiratory outcomes and resource use to determine if structured weaning improves patient care and efficiency.

Why it matters

Who can join: the full rules

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

Where it's running

• Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
  Milan, Lombardy, Italy Recruiting
• Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
  Catania, Sicily, Italy Not yet recruiting

Study contacts

• Study coordinator: Michele Mondoni, MD
• Email: michele.mondoni@unimi.it
• Phone: +39 0240223025

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.