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

Recruiting now · Not applicable

Conditions studied: Critical Care, Oxygen Therapy, Mechanical Ventilation

In brief

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.

Key facts

Study ID

NCT06816706

Run by

Jian-Xin Zhou

People needed

20

Starts

2025-03-01

Expected to finish

2025-12-30

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Beijing Shijitan Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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