An interventional study of Protocolized HFNC weaning in Acute Respiratory Failure (ARF), sponsored by University of Milan. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Milan · Not applicable, Interventional, and Other
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.
University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment.
Protocolized weaning using ROX index + FiO₂
Other: Protocolized HFNC weaning
HFNC 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.
Time frame: Within 48 hours after the first separation attempt
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.
Time frame: Within 48 hours after the second separation attempt
Length of hospital stay
Comparison of total hospital stay and post-weaning hospital stay between the two study arms.
Time frame: From the day of hospital admission until the day of hospital discharge, assessed up to 60 days; and from the day of HFNC discontinuation until the day of hospital discharge, assessed up to 60 days.
In-hospital and 30-day mortality
Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
Time frame: From the day of admission to the day of discharge or death (in-hospital mortality) and from the day of admission to 30-day after discharge (30-day mortality)
Predictors of weaning success
Identification of clinical and respiratory variables associated with successful HFNC weaning.
Time frame: From enrollment through hospital discharge, an average of 10 days.
Number of days of HFNC treatment from initiation to definitive discontinuation
Number of days of HFNC treatment from initiation to definitive discontinuation
Time frame: From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
Predictors of HFNC treatment duration
Demographic, clinical, radiological and laboratory variables associated with HFNC treatment duration
Time frame: From HFNC initiation through hospital discharge, an average of 10 days
Prevalence of diaphragmatic dysfunction assessed by diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound between the two study arms.
Comparison of the prevalence of diaphragmatic dysfunction assessed by diaphragmatic ultrasound between patients with successful HFNC weaning and those with weaning failure. Diaphragmatic function will be evaluated using diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound.
Time frame: 30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
Changes in diaphragmatic function
Evaluation of diaphragmatic ultrasound parameters before and after HFNC discontinuation.
Time frame: Before HFNC discontinuation and within 48 hours after weaning attempt
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for May 2028, 24 months later.
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