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

RecruitingNAAges 18 Years - anyAllJian-Xin Zhou
NCT06816706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Modified high flow tracheal oxygen-40L/min
  • Standard high flow tracheal oxygen-40L/min
  • T-piece
  • Modified high-flow tracheal oxygen-60L/min
  • Standard high-flow tracheal oxygen-60 L/min
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Where

1 site
Beijing Shijitan Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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