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Clinical Trials in China / NCT06816706
Recruiting Not applicable

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

NCT06816706 · tracked via the Priya Life Science China tracker
Sponsor
Jian-Xin Zhou
Phase
Not applicable
Started
2025-03-01
Last updated
2025-03-21

Condition(s) studied

Critical CareOxygen TherapyMechanical Ventilation

Investigational drug(s) / intervention(s)

Modified high flow tracheal oxygen-40L/minStandard high flow tracheal oxygen-40L/minT-pieceModified high-flow tracheal oxygen-60L/minStandard high-flow tracheal oxygen-60 L/min

Modified high flow tracheal oxygen-40L/min: Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.

Standard high flow tracheal oxygen-40L/min: Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.

T-piece: T-piece will be performed.

Modified high-flow tracheal oxygen-60L/min: Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.

Standard high-flow tracheal oxygen-60 L/min: Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing Beijing Municipality Recruiting

More Jian-Xin Zhou trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06816706 on ClinicalTrials.gov ↗ ← All trials in China