NCT07638293 Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure
| NCT ID | NCT07638293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milan |
| Condition | Acute Respiratory Failure (ARF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2026-05-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07638293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure (ARF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638293 currently recruiting?
Yes, NCT07638293 is actively recruiting participants. Contact the research team at michele.mondoni@unimi.it for enrollment information.
Where is the NCT07638293 trial being conducted?
This trial is being conducted at Milan, Italy, Catania, Italy.
Who is sponsoring the NCT07638293 clinical trial?
NCT07638293 is sponsored by University of Milan. The trial plans to enroll 148 participants.