Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes with Different Cuff Shapes in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- The incidence of postoperative sore throat
研究概览
简要总结
This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat
详细描述
Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation
排除标准
- •Age < 18 years or age > 80 years
- •Diseases or anatomic abnormalities in the neck, larynx, or pharynx
- •Combined surgery such as breast reconstruction
- •Active pulmonary disease
- •Morbid obesity (body mass index ≥ 40 kg/m2)
- •Pregnancy
- •Refusal to join the study
结局指标
主要结局
The incidence of postoperative sore throat
时间窗: Postoperative 48 hours
The severity of postoperative sore throat
时间窗: Postoperative 48 hours
1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)
次要结局
- Intraoperative fentanyl consumption(The end of surgery)
- Intraoperative propofol consumption(The end of surgery)
- Intraoperative rocuronium consumption(The end of surgery)
- The degree of subglottic injury(Intraoperative (The time point at extubation))
研究者
Wei-Cheng Tseng
Principal Investigator
Tri-Service General Hospital