NCT06816706

Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials

Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jian-Xin Zhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.

Detailed description

A spontaneous breathing trial (SBT) is a crucial step in the weaning and extubation process for assessing extubation tolerance. However, the optimal approach for conducting SBTs remains a topic of debate. High-flow nasal oxygen has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. High-flow oxygen therapy can also be applied via an artificial airway as high-flow tracheal oxygen. Previous studies have identified this therapy as a potential alternative for SBTs. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway as well as a more open circuit. To address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thereby simulating the physiological effects of HFNC. This study is a prospective randomized crossover physiological study designed to compare the effects of standard and modified high-flow tracheal oxygen versus T-piece during spontaneous breathing trials. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.

Conditions

• Critical Care
• Oxygen Therapy
• Mechanical Ventilation

Interventions

Type	Name	Description
PROCEDURE	Modified high flow tracheal oxygen-40L/min	Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
PROCEDURE	Standard high flow tracheal oxygen-40L/min	Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
PROCEDURE	T-piece	T-piece will be performed.
PROCEDURE	Modified high-flow tracheal oxygen-60L/min	Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
PROCEDURE	Standard high-flow tracheal oxygen-60 L/min	Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2025-02-10
• Last updated: 2025-03-21

Locations

1 site across 1 country: China