High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients

Recruiting now · Not applicable

Conditions studied: Tracheostomized Patients, Mechanical Ventilation Weaning, High Flow Oxygen Therapy

In brief

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.

Key facts

Study ID: NCT07559591
Run by: King Faisal Specialist Hospital & Research Center
People needed: 88
Starts: 2026-05-17
Expected to finish: 2027-05-01
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

King Faisal Specialist Hospital and Research Centre — Riyadh, Saudi Arabia (enrolling)

Full record on ClinicalTrials.gov

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