HFTO Via Tracheal Intubation in Neurocritical Patients

NCT ID: NCT07257016

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-08-31

Brief 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.

Detailed Description

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.

Conditions

High Flow Oxygen Therapy; Neuro ICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFTO

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

Group Type: EXPERIMENTAL

HFTO

Intervention Type: DEVICE

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%.

PSV

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

Group Type: ACTIVE_COMPARATOR

PSV

Intervention Type: DEVICE

Continue low-level pressure support ventilation using a mechanical ventilator. Parameter settings: Pressure support (PS) 5-8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤ 0.40.

Interventions

HFTO

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%.

Intervention Type: DEVICE

PSV

Continue low-level pressure support ventilation using a mechanical ventilator. Parameter settings: Pressure support (PS) 5-8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤ 0.40.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chen Guangqiang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chen Guangqiang

Role: CONTACT

acapoftea2021@163.com

8615910783162

References

Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.

Reference Type: BACKGROUND

PMID: 27762595 (View on PubMed)

Janssen ML, Weller D, Endeman H, Heunks LM, Wils EJ. Physiological Effects of High-Flow Tracheal Oxygen in Tracheostomized Patients Weaning From Mechanical Ventilation. Respir Care. 2024 Sep 26;69(10):1336-1344. doi: 10.4187/respcare.11755.

Reference Type: BACKGROUND

PMID: 38772682 (View on PubMed)

Other Identifiers

HX-B-2025-016

Identifier Type: -

Identifier Source: org_study_id