High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients
High Flow Tracheal Oxygen for Weaning of Tracheostomized Mechanically Ventilated Patients: A Pilot Randomised Controlled Trial (HFTO WEAN Trial)
King Faisal Specialist Hospital & Research Center
88 participants
May 17, 2026
INTERVENTIONAL
Conditions
Summary
In this pilot randomized controlled trial (RCT), the investigators aim to explore the feasibility of conducting a powered RCT that examines the efficacy and safety of high flow tracheal oxygen (HFTO) in weaning critically ill tracheostomy patients from mechanical ventilation. Objective of the study 1. To assess the feasibility of conducting a larger RCT as primary objective. 2. To explore the effect of using HFTO in mechanically ventilated tracheostomized critically ill patients on ventilator-free days (VFD) compared to standard of care method using tracheal mask (TM) as secondary objective.
Eligibility
Inclusion Criteria4
- Adults ≥ 18 years of age
- Intensive care unit (ICU) patients with tracheostomy inserted during the index ICU admission.
- Mechanically ventilated for ≤60 days.
- Successful spontaneous breathing trial for 1 hour.
Exclusion Criteria5
- Planned tracheostomy post head and neck surgery with ICU stay less than 48 hours
- Patient transferred from another hospital only if the intubation and tracheostomy dates are unavailable, otherwise would be eligible.
- Patient with an imminent plan for palliation and comfort care.
- Patient or substitute decision-maker declines consent to the study.
- The treating physician declines consent to the study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
High-flow tracheal oxygen for weaning tracheosstomized mechanically ventilated patients
Standard of care using tracheal mask (TM) oxygen for weaning tracheostomized mechanically ventilated patients
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07559591