Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- tracheal tube-related tongue injury
研究概览
简要总结
Article Summary
- Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia.
- There is a lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
- This is a protocol of a single-center, prospective, paralled-group clinical trial based on the measurement of dynamic changes in pressure between the tracheal tube and the tongue in different position during the surgery.
- The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include the time to first successful recovery of oral intake of fluids and solid food and airway-related events.
- This trial aims to find the best indicators for tracheal tracheal tube-related tongue injury and to provide solid basis for optimizing airway protection strategies and surgical positioning.
详细描述
Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, leading to severe throat pain, dysphagia, and respiratory function impairment. There is a lack of indicators and clinical awareness of this issue. Therefore we have designed this study to accurately monitor the tracheal tube-tongue pressure in different surgical position during general anesthesia.
Method This is a prospective, single-center observational study. Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied will be enrolled. Patients will be divided into supine position (Supine group) and the high-risk positions (Flexion group) groups. Dynamic changes in pressure between the tracheal tube and the tongue are measured. All patients will be followed up until 7 days after operation. Primary endpoint is tracheal tube-related tongue injury. Secondary outcomes include the time to first successful recovery of oral intake of fluids and solid food, and airway-related events.
Discussion The study aims to explore the risk factors and pressure thresholds for tracheal tracheal tube-related tongue injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85 years old
- •Scheduled for elective surgery with tracheal intubation under general anesthesia, with operation duration ≥2 hours
- •The intended surgical position will be supine, prone, cervical traction or beach chair position
- •Obtained informed consent
排除标准
- •Informed consent is not obtained
- •Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway
- •History of head and neck radiotherapy
- •Deformity, trauma, infection and active bleeding exist in the mouth and tongue
- •Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive pulmonary disease, laryngeal osteomalacia
- •Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction
- •Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia, severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac stenosis and other basic diseases
- •Postoperative total parenteral nutrition therapy is planned
结局指标
主要结局
tracheal tube-related tongue injury
时间窗: Starting from the time after surgery till post-operative day 7 (POD7)
The primary composite endpoint is assessed as incidence of tracheal tube-related tongue injury, which is either the state of severe sore throat (VAS≥4), dysphagia after extubation, or any of the symptoms of macroglossia.
次要结局
- time of first smooth water intake(Starting from the time after surgery till post-operative day 7 (POD7))
- time of first smooth solid food intake(Starting from the time after surgery till post-operative day 7 (POD7))
- airway related events(Starting from the time after surgery till post-operative day 7 (POD7))
研究者
Li Fang Wang
attending doctor
China-Japan Friendship Hospital