HFTO Via Tracheal Intubation in Neurocritical Patients (NCT07257016) | Clinical Trial Compass
CompletedNot Applicable
HFTO Via Tracheal Intubation in Neurocritical Patients
China24 participantsStarted 2025-12-15
Plain-language summary
Neurocritical patients often require prolonged invasive ventilation due to impaired respiratory drive and airway protection deficits. While early weaning reduces complications and costs, these patients frequently pass spontaneous breathing trials (SBT) yet remain intubated solely for airway protection.
Current practice maintains low-level pressure support ventilation (5-8 cmH₂O) to offset endotracheal tube resistance. However, prolonged ventilation increases risks of ventilator-associated pneumonia (VAP) and diaphragm dysfunction. Emerging evidence suggests appropriately sized tubes may not substantially increase work of breathing (WOB).
High-flow oxygen therapy (HFOT) delivers heated, humidified oxygen at high flow rates, reducing WOB and improving oxygenation and comfort. While validated for tracheostomized patients, HFOT via tracheal intubation (HFOT-TI) remains unstudied in neurocritical populations during early weaning.
This study aims to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection.
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:
* Age ≥ 18 years.
* Post-neurosurgical or brain injury patients with stable intracranial status (Glasgow Coma Scale ≥ 9, Richmond Agitation-Sedation Scale score -2 to +1).
* Successful completion of a 30-minute T-piece spontaneous breathing trial (per standard SBT failure criteria).
* Poor airway protection capacity (STAGE score \< 6) necessitates ongoing intubation for respiratory support, as determined by the attending physician.
* Signed informed consent (by patient or legal representative).
Exclusion Criteria:
* Contraindications to esophageal pressure monitoring (e.g., esophageal varices, recent esophageal surgery).
* History of chronic respiratory diseases (e.g., COPD, severe asthma).
* Chronic heart failure (NYHA class III-IV) or severe arrhythmia.
* Body Mass Index (BMI) \> 30 kg/m².
* Pregnancy.
* Anticipated need for tracheostomy without extubation attempt
* Withdrawal of life-sustaining treatment
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.