Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized P… (NCT06816745) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
China20 participantsStarted 2025-02-20
Plain-language summary
High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.
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.
. Respiratory and oxygenation instability (respiratory rate \> 35bpm or oxygen saturation measured by pulse oximetry \<90%)
. Neuromuscular diseases or phrenic nerve injury
. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
. Pneumothorax or placement of a chest drainage
. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
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
Mean expiratory airway pressure
Timeframe: From enrollment to the end of treatment at 4 hours
2
Positive end-expiratory pressure
Timeframe: From enrollment to the end of treatment at 4 hours
3
Change of end-expiatory lung volume
Timeframe: From enrollment to the end of treatment at 4 hours