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 calculated as the ratio of peripheral oxygen saturation (SpO₂) divided by fraction of inspired oxygen (FiO₂) to respiratory rate. The primary objective of this study is to compare a standardized HFNC weaning strategy based on ROX index and FiO₂ thresholds with usual clinical practice based on physician judgment. The primary outcome is weaning failure at the first attempt, defined as the need for HFNC reinstitution, noninvasive or invasive mechanical ventilation, or death within 48 hours after discontinuation.
Age ≥18 years
Presence of acute respiratory failure (ARF)
Receiving HFNC treatment for ≥24 hours
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
Parallel
Protocolized HFNC weaning
Other interventionHFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
Weaning failure
To compare the percentage of patients who fail HFNC weaning within 48 hours after the first separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
Second-attempt weaning success
To compare the percentage of patients who fail HFNC weaning within 48 hours after the second separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
Length of hospital stay
Comparison of total hospital stay and post-weaning hospital stay between the two study arms.
In-hospital and 30-day mortality
Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
Predictors of weaning success
Identification of clinical and respiratory variables associated with successful HFNC weaning.
Click on the lead sponsor to view all of their trials.
