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High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.
High-flow nasal oxygen therapy 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. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.
High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. 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, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. 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 | Experimental | Modified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients. |
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| Standard high flow tracheal oxygen | Experimental | Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified high flow tracheal oxygen | Procedure | Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Tracheostomy with stable spontaneous breathing.
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 | Beijing | Beijing Municipality | 100038 | China |
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| Standard high flow tracheal oxygen | Procedure | Standard high-flow tracheal oxygen with flow rates of 40 L/min and 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 4 hours |