Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean expiratory airway pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tracheostomy with stable spontaneous breathing.
排除标准
- •Age younger than 18 years old
- •Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60 bpm)
- •Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygen saturation measured by pulse oximetry <90%)
- •Neuromuscular diseases or phrenic nerve injury
- •Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
- •Pneumothorax or placement of a chest drainage
- •Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
- •Anticipating withdrawal of life support
结局指标
主要结局
Mean expiratory airway pressure
时间窗: From enrollment to the end of treatment at 4 hours
Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen.
Positive end-expiratory pressure
时间窗: From enrollment to the end of treatment at 4 hours
Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen.
Change of end-expiatory lung volume
时间窗: From enrollment to the end of treatment at 4 hours
Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen.
次要结局
- Respiratory rate(From enrollment to the end of treatment at 4 hours)
- Dynamic transpulmonary pressure(From enrollment to the end of treatment at 4 hours)
- Esophageal pressure-time product(From enrollment to the end of treatment at 4 hours)
- Tidal volume(From enrollment to the end of treatment at 4 hours)
- Pulse oxygen saturation(From enrollment to the end of treatment at 4 hours)
- End-tidal carbon dioxide(From enrollment to the end of treatment at 4 hours)
- Respiratory muscle pressure(From enrollment to the end of treatment at 4 hours)
- Tidal swing of esophageal pressure(From enrollment to the end of treatment at 4 hours)
研究者
Jian-Xin Zhou
Professor
Capital Medical University