An interventional study of Modified high flow tracheal oxygen-40L/min and Standard high flow tracheal oxygen-40L/min in Critical Care, Oxygen Therapy and Mechanical Ventilation, sponsored by Jian-Xin Zhou. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Jian-Xin Zhou · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 20 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
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Exclusion Criteria:
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Procedure: Modified high flow tracheal oxygen-40L/min
Standard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Procedure: Standard high flow tracheal oxygen-40L/min
T-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Procedure: T-piece
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Procedure: Modified high-flow tracheal oxygen-60L/min
Standard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Procedure: Standard high-flow tracheal oxygen-60 L/min
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
T-piece will be performed.
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
Mean expiratory airway pressure
Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Positive end-expiratory pressure
Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Change of end-expiatory lung volume
Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Respiratory rate
Respiratory rate will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Tidal volume
Tidal volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide
End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation
Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure
Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Respiratory muscle pressure
Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Time frame: From enrollment to the end of treatment at 4 hours
Plan to share: No
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Jian-Xin Zhou