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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-protocolized weaning | No Intervention | Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment. | |
| Protocolized weaning | Experimental | Protocolized weaning using ROX index + FiOâ‚‚ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolized HFNC weaning | Other | HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40% |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 FiOâ‚‚ cut-offs versus standard clinical practice guided by physician judgment. | Within 48 hours after the first separation attempt |
| Measure | Description | Time Frame |
|---|---|---|
| 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 FiOâ‚‚ cut-offs versus standard clinical practice guided by physician judgment. | Within 48 hours after the second separation attempt |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Mondoni, MD | Contact | +39 0240223025 | michele.mondoni@unimi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy) | Recruiting | Milan | Lombardy | 20142 | Italy |
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| Length of hospital stay |
Comparison of total hospital stay and post-weaning hospital stay between the two study arms. |
| 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. | 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. | 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 | 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 | 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. | 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. | Before HFNC discontinuation and within 48 hours after weaning attempt |
| Pulmonology Unit, University Hospital "G. Rodolico-San Marco" | Not yet recruiting | Catania | Sicily | 95123 | Italy |
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