Capital Medical University Beijing Tiantan Hospital
Beijing, 100070, China
NCT Number: NCT07257016
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Beijing, 100070, China
Neurocritical patients, including those with traumatic brain injury, stroke, or intracranial hemorrhage, often require prolonged mechanical ventilation due to impaired respiratory drive or airway protection needs. Weaning these patients from invasive ventilation involves two key stages: liberation from mechanical support and extubation. Early weaning reduces complications, accelerates recovery, and lowers healthcare costs. Clinical guidelines advocate early weaning assessments for patients ventilated for over 24 hours, followed by spontaneous breathing trials (SBT) to confirm readiness for independent breathing. While patients passing SBT are typically extubated promptly, neurocritical patients often face delayed extubation due to impaired consciousness or inadequate airway protection, despite adequate respiratory function. In these cases, the tracheal tube primarily ensures airway protection rather than ventilatory support.
Traditionally, low-level ventilatory support (e.g., pressure support of 5-8 cmH₂O) is used to counter the inspiratory resistance of the tracheal tube and provide humidified gas. However, prolonged ventilation, even at minimal levels, may increase risks such as ventilator-associated pneumonia and diaphragm dysfunction. Evidence indicates that appropriately sized tracheal tubes may not substantially increase the work of breathing (WOB), and some patients can compensate for this resistance without ventilatory support.
High-flow oxygen therapy (HFOT), delivered via nasal cannula or tracheostomy, provides heated, humidified oxygen at high flow rates, enhancing oxygenation, reducing WOB, and improving patient comfort. Emerging evidence supports its role in facilitating weaning in tracheostomized patients and during SBT in intubated patients. However, the safety and feasibility of HFOT via tracheal intubation (HFOT-TI) in neurocritical patients during early weaning remain largely unexplored. Given the prolonged airway protection needs in this population, HFOT-TI may serve as an effective bridge to extubation, potentially minimizing prolonged ventilatory support and associated complications.
Investigators aimed to evaluate the safety and feasibility of HFOT-TI in neurocritical patients who have passed SBT but require ongoing airway protection. Investigators assessed changes in respiratory parameters and safety outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use a high-flow oxygen therapy system connected to the endotracheal tube via a dedicated adapter. Initial settings: Flow rate 40 L/min, FiO₂ titrated to maintain patient SpO₂ ≥ 95%.
Continue low-level pressure support ventilation using a mechanical ventilator. Parameter settings: Pressure support (PS) 5-8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤ 0.40.
Time frame: 48 hours
PTPes is defined as the area enclosed by the Pcw and Pes curves during the inspiratory phase, multiplied by the respiratory rate.
Time frame: 48 hours
Pmus is defined as the maximum difference between the chest wall recoil pressure (Pcw) and the esophageal pressure (Pes) during inspiration.
Time frame: 28 days
Ventilator-Free Days during the first 28 days
Capital Medical University
Other
High-Flow Oxygen Therapy Via Tracheal Intubation in Neurocritical Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06357390
High Flow Oxygen Therapy
Taipei, Taiwan
View Trial DetailsNCT04109560
Acute Hypercapnic Respiratory Failure, COPD Exacerbation
CABA, Argentina
View Trial DetailsNCT07559591
Critical Illness, Disease Attributes
Riyadh, Saudi Arabia
View Trial DetailsNCT07168213
Acute Respiratory Failure, High Flow Oxygen Therapy
Québec, Quebec, Canada
View Trial Details