HFTO Via Tracheal Intubation in Neurocritical Patients

NCT07257016 | Completed

• 1 other identifier: HX-B-2025-016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

High Flow Oxygen Therapy; Neuro ICU

Outcome Measures

Primary Outcomes (1)

• PTPes

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

  48 hours

Secondary Outcomes (2)

• Pmus

  48 hours

• Ventilator-Free Days

  28 days

Study Arms (2)

HFTO

EXPERIMENTAL

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

Device: HFTO

PSV

ACTIVE COMPARATOR

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

Device: PSV

Interventions

HFTO 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%.

HFTO

PSV 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.

PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Publications (2)

• 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.

  PMID: 27762595 BACKGROUND

• 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.

  PMID: 38772682 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: December 15, 2025
• Primary Completion: February 27, 2026
• Study Completion: April 28, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)