Protocolized HFNC weaning
OtherHFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
NCT Number: NCT07638293
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy), Milan, Lombardy, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
Time frame: Within 48 hours after the first separation attempt
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 second separation attempt
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: 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.
Comparison of total hospital stay and post-weaning hospital stay 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)
Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
Time frame: From enrollment through hospital discharge, an average of 10 days.
Identification of clinical and respiratory variables associated with successful HFNC weaning.
Time frame: From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
Number of days of HFNC treatment from initiation to definitive discontinuation
Time frame: From HFNC initiation through hospital discharge, an average of 10 days
Demographic, clinical, radiological and laboratory variables associated with HFNC treatment duration
Time frame: 30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
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: Before HFNC discontinuation and within 48 hours after weaning attempt
Evaluation of diaphragmatic ultrasound parameters before and after HFNC discontinuation.
Contact information is provided by the study sponsor or research team.
University of Milan
Other
Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure: A Randomized Clinical Trial
Acronym: WHIP
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