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 range18 Years

SexALL

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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

What they're measuring

PTPes

Timeframe: 48 hours

Trial details

NCT IDNCT07257016

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-27