High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients (NCT07559591) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients
Saudi Arabia88 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Consent Rate
Timeframe: 1 Year
2
Recruitment Rate
Timeframe: 1 Year
3
Protocol Adherence
Timeframe: 1 Year
Trial details
NCT IDNCT07559591
SponsorKing Faisal Specialist Hospital & Research Center