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High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients

RecruitingNAAges 18 Years - anyAllKing Faisal Specialist Hospital & Research Center
NCT07559591 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • High-flow tracheal oxygen (HFTO)
  • Tracheal Mask (TM)
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Where

1 site
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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