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NCT07714564

Overview

NCT ID: NCT07714564
Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER
Official Title: Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial
Brief 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.
Conditions: Tracheostomy
Mechanical Ventilation
Hypoxemic Respiratory Failure
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 500Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Domenico Luca Grieco, MDContact
domenicoluca.grieco@unicatt.it+393397681623

Similar Studies

Participant Group/Arms

High-flow oxygenExperimental

Maximum tolerated flow (up to 50-60 L/min), humidification chamber temperature set at 37 °C and FiO2 titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. Flow reduction will be allowed in case of intolerance and/or according to patients' requirements: flow ≥30 L/min will be mandatory in all enrolled patients. Weaning from high-flow will not be considered before 24 hours from study enrolment and will be discouraged until the patient is considered for intensive care unit discharge. After weaning, patients will receive conventional oxygen.

Other: Oxygen therapy

Conventional oxygenActive Comparator

Patients will receive standard oxygen therapy via a heat and moisture exchanger (Tracheolife) or a Venturi tracheal mask device connected to a humidified source of oxygen. Oxygen flow or VenturiMask FiO2 will be titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. The use of tracheal high-flow will not be allowed under any circumstances in patients in this group.

Other: Oxygen therapy