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临床试验/NCT07257016
NCT07257016已完成不适用

High-Flow Oxygen Therapy Via Tracheal Intubation in Neurocritical Patients

Capital Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
PTPes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

研究组 & 干预措施

HFTO

Experimental

Patients with delayed extubation receiving high-flow tracheal oxygen therapy.

干预措施: HFTO (Device)

PSV

Active Comparator

Patients with delayed extubation receiving low-level pressure support ventilation.

干预措施: PSV (Device)

结局指标

主要结局

PTPes

时间窗: 48 hours

PTPes is defined as the area enclosed by the Pcw and Pes curves during the inspiratory phase, multiplied by the respiratory rate.

次要结局

  • Pmus(48 hours)
  • ΔPes(48 hours)
  • Ventilator-Free Days(28 days)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Guangqiang

Principal Investigator

Capital Medical University

研究点 (1)

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