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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified high flow tracheal oxygen-40L/min | Experimental | Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
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| Standard high flow tracheal oxygen-40L/min | Experimental | Standard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
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| T-piece | Experimental | T-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
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| Modified high-flow tracheal oxygen-60L/min | Experimental | Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
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| Standard high-flow tracheal oxygen-60L/min | Experimental | Standard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified high flow tracheal oxygen-40L/min | Procedure | Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean expiratory airway pressure | Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece. | 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. | 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. | From enrollment to the end of treatment at 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Respiratory rate will be measured during standard and modified high-flow tracheal oxygen versus T-piece. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Xin Zhou, MD, PhD | Contact | 8610 6392 6666 | zhoujx.cn@icloud.com | |
| Shan-Shan Xu, MD | Contact | 8618501219133 | 1004496285@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-Xin Zhou, MD, PhD | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Recruiting | Beijing | Beijing Municipality | 100038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40962338 | Derived | Xu SS, Zhang RZ, An X, Miao MY, Wang YF, Li HL, Zhou JX. Physiological effects of high-flow oxygen via endotracheal tube versus T-piece strategies during spontaneous breathing trials: a study protocol and statistical analysis for a single-centre randomised crossover study. BMJ Open. 2025 Sep 16;15(9):e105360. doi: 10.1136/bmjopen-2025-105360. |
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| Standard high flow tracheal oxygen-40L/min | Procedure | Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed. |
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| T-piece | Procedure | T-piece will be performed. |
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| Modified high-flow tracheal oxygen-60L/min | Procedure | Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed. |
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| Standard high-flow tracheal oxygen-60 L/min | Procedure | Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 4 hours |