Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT07638293
Recruiting Not applicable

Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure

NCT07638293 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milan
Phase
Not applicable
Started
2026-05-15
Last updated
2026-06-10

Condition(s) studied

Acute Respiratory Failure (ARF)

Investigational drug(s) / intervention(s)

Protocolized HFNC weaning

Protocolized HFNC weaning: HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy) Milan Lombardy Recruiting
Pulmonology Unit, University Hospital "G. Rodolico-San Marco" Catania Sicily Not Yet Recruiting

More University of Milan trials in Italy

Keratized Mucosa in CG Implant Placement: CTG vs Flapless Recruiting
Safety of Bronchoscopy in Patients With Interstitial Lung Disease Starting soon
Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment Recruiting
Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD Starting soon
Effect of add-on Doxofylline on Lung Function in Stable COPD Starting soon

Other trials for the same condition

Bed Side Assessment in Patients With Acute Respiratory Failure Under Invasive Mechanical Ventilation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07638293 on ClinicalTrials.gov ↗ ← All trials in Italy