High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients

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.

NCT Number	NCT07559591
Lead Sponsor	King Faisal Specialist Hospital & Research Center
Conditions	Tracheostomized Patients, Mechanical Ventilation Weaning, High Flow Oxygen Therapy
Enrollment	88 participants
Start Date	2026-05-17
Primary Completion	2027-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-02