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Recruiting NCT06816706

NCT06816706 Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials

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Clinical Trial Summary
NCT ID NCT06816706
Status Recruiting
Phase
Sponsor Jian-Xin Zhou
Condition Critical Care
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2025-03-01
Primary Completion 2025-11-30

Trial Parameters

Condition Critical Care
Sponsor Jian-Xin Zhou
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-01
Completion 2025-11-30
Interventions
Modified high flow tracheal oxygen-40L/minStandard high flow tracheal oxygen-40L/minT-piece

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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.

Eligibility Criteria

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

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