Trcheal High-flow for Weaning From Mechanical Ventilation

NCT07714564 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Not applicable

Started

2026-10-01

Last updated

2026-07-20

Condition(s) studied

TracheostomyMechanical VentilationHypoxemic Respiratory Failure

Investigational drug(s) / intervention(s)

Oxygen therapy

Oxygen therapy: Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.

Study summary

Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Tracheostomy * Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation * Hypoxemia (PaO2/FiO2\<300) while on mechanical ventilation Exclusion Criteria: * anticipated need for long-term mechanical ventilation * scheduled reconnections to mechanical ventilation * neuromuscular disease * chronic ventilator dependence * planned nocturnal home ventilation

Primary outcome measure(s)

Succesful weaning — Day 7 after randomization
proportion of patients weaned from mechanical ventilation at day 7 after randomization. Weaning is defined as being disconnected from the mechanical ventilator on day 7 and remaining off the ventilator for at least the subsequent 48 consecutive hours without reconnection.

Trial sites (1)

Facility	City	Region	Status
ICU, Fondazione Policlinico A. Gemelli IRCCS	Rome	Italy

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Recruiting

Analysis of the Role of AIRE in Autoimmune Neurological Diseases Associated With Autoantibodies Recruiting

Transition From Pediatric to Adult Care in Epilepsy Recruiting

Predictive Biomarkers Including miRNA-based Tumor Signatures in Diffuse Large B Cell Lymphoma (R/R DLBCL) (MIMOSA) Starting soon

Prospective Evaluation of NfL as a Biomarker in ATTRv Active, not recruiting

Other trials for the same condition

TRacheal Cuff PRessure Evaluation Study Starting soon

Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit. Recruiting

Intelligent Lung Support in the Intensive Care Unit Recruiting

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome Recruiting

Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure 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 NCT07714564 on ClinicalTrials.gov ↗ ← All trials in Italy