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

Not Applicable

Recruiting

• Conditions: Critical Care; Oxygen Therapy; Mechanical Ventilation

• Registration Number: NCT06816706
• Lead Sponsor: Jian-Xin Zhou

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-10
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Mechanical ventilation for more than 24 hours
2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials

Exclusion Criteria

1. Age younger than 18 years old
2. Pregnancy
3. Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60 bpm)
4. Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygen saturation measured by pulse oximetry <90%)
5. Neuromuscular diseases or phrenic nerve injury
6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
7. Pneumothorax or placement of a chest drainage
8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
9. Anticipating withdrawal of life support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change of end-expiatory lung volume	From enrollment to the end of treatment at 4 hours	Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Positive end-expiratory pressure	From enrollment to the end of treatment at 4 hours	Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Mean expiratory airway pressure	From enrollment to the end of treatment at 4 hours	Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	From enrollment to the end of treatment at 4 hours	Respiratory rate will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Dynamic transpulmonary pressure	From enrollment to the end of treatment at 4 hours	Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
End-tidal carbon dioxide	From enrollment to the end of treatment at 4 hours	End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Tidal volume	From enrollment to the end of treatment at 4 hours	Tidal volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Pulse oxygen saturation	From enrollment to the end of treatment at 4 hours	Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Esophageal pressure-time product	From enrollment to the end of treatment at 4 hours	Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Tidal swing of esophageal pressure	From enrollment to the end of treatment at 4 hours	Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Respiratory muscle pressure	From enrollment to the end of treatment at 4 hours	Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China