High Flow Tracheal Oxygen to Help Wean Tracheostomy Patients from Ventilation
Official title: High Flow Tracheal Oxygen for Weaning of Tracheostomized Mechanically Ventilated Patients: A Pilot Randomised Controlled Trial (HFTO WEAN Trial)
Run by King Faisal Specialist Hospital & Research Center · NCT07559591 · Data updated 2026-11-12
This trial tests whether delivering high-flow oxygen directly through the trachea helps tracheostomized patients on mechanical ventilation try to come off ventilation faster than standard tracheal mask therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | King Faisal Specialist Hospital & Research Center Academic / other |
| Locations | 1 site (Riyadh) |
| Status | Recruiting |
| Started | May 17, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07559591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) in the ICU with a tracheostomy, on mechanical ventilation for up to 60 days, and who have passed a 1-hour spontaneous breathing trial.
✕Probably not a fit
Patients who do not respond to high-flow tracheal oxygen or who are not candidates for weaning may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized trial will compare high flow tracheal oxygen to standard tracheal mask therapy in critically ill adults with tracheostomies who are ready to wean from mechanical ventilation. The main goal is to see if a larger study is feasible and to explore whether HFTO can increase ventilator-free days. The study explains the rationale for HFTO, including its potential to improve oxygenation, reduce breathing work, and help recruit alveoli while delivering heated, humidified gas. Eligible participants are adults with a tracheostomy in the ICU who have been mechanically ventilated for up to 60 days and have passed a 1-hour spontaneous breathing trial. Outcomes include feasibility metrics and ventilator-free days as a secondary endpoint.
Why it matters
Potential benefit: If successful, HFTO could shorten time on ventilation and reduce complications associated with prolonged mechanical support.
How similar studies have gone: HFNC and other high-flow strategies have shown potential in improving oxygenation and reducing escalation of respiratory support in prior trials, but this exact tracheal route for weaning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults ≥ 18 years of age 2. Intensive care unit (ICU) patients with tracheostomy inserted during the index ICU admission. 3. Mechanically ventilated for ≤60 days. 4. Successful spontaneous breathing trial for 1 hour. Exclusion Criteria: 1. Planned tracheostomy post head and neck surgery with ICU stay less than 48 hours 2. Patient transferred from another hospital only if the intubation and tracheostomy dates are unavailable, otherwise would be eligible. 3. Patient with an imminent plan for palliation and comfort care. 4. Patient or substitute decision-maker declines consent to the study. 5. The treating physician declines consent to the study.
Where it's running
-
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia Recruiting
Study contacts
- Principal investigator: Zainab Al Duhailib, MBBS, MSc, EDIC — King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia
- Study coordinator: Zainab Al Duhailib, MBBS, MSc, EDIC
- Email: zainajd@gmail.com
- Phone: 00966112162919
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.