High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients (NCT07559591) | Clinical Trial Compass
RecruitingNot Applicable
High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients
Saudi Arabia88 participantsStarted 2026-05-17
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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