A Prospective Observational Study on the Effect of Changes in Endotracheal Tube Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Patients Undergoing Robot-Assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Pharyngolaryngeal Complications
研究概览
简要总结
The goal of this observational study is to evaluate how changes in endotracheal tube (ETT) cuff pressure during robot-assisted radical prostatectomy (RARP) affect postoperative throat-related symptoms. The main question the study aims to answer is: Do pneumoperitoneum and the steep Trendelenburg position used in robotic prostate surgery increase ETT cuff pressure and lead to a higher incidence of postoperative pharyngolaryngeal complications such as sore throat, hoarseness, or dysphagia? This study includes 50 male patients undergoing elective radical prostatectomy under general anesthesia, with 25 patients in the open surgery group and 25 in the robotic-assisted group. The ETT cuff pressure is initially adjusted to the lowest level that prevents air leakage (20-35 cmH#O) and is continuously monitored throughout surgery. Measurements are recorded at specific intraoperative time points related to pneumoperitoneum and positioning. After surgery, patients are evaluated at 2 and 24 hours postoperatively for throat-related symptoms such as sore throat, hoarseness, dysphagia, and cough. The results are expected to clarify whether intraoperative factors unique to robotic surgery contribute to increased cuff pressure and postoperative discomfort, emphasizing the importance of continuous cuff pressure monitoring and timely adjustment for patient safety.
详细描述
Endotracheal tube (ETT) cuff pressure management is critical in maintaining airway safety during general anesthesia. Excessive cuff pressure may cause mucosal ischemia and postoperative complications such as sore throat, hoarseness, and dysphagia, while insufficient pressure can lead to air leakage and aspiration risk. During robot-assisted laparoscopic radical prostatectomy (RARP), patients are placed in a steep Trendelenburg position with pneumoperitoneum, which may significantly affect airway mechanics and ETT cuff pressure due to increased intrathoracic and airway pressures. This observational study aims to investigate how intraoperative factors unique to robotic surgery-particularly pneumoperitoneum and Trendelenburg positioning-affect ETT cuff pressure and postoperative pharyngolaryngeal outcomes. Fifty adult male patients scheduled for elective radical prostatectomy under general anesthesia are included. Twenty-five undergo open surgery, and twenty-five undergo robotic-assisted surgery. After intubation, the ETT cuff is inflated to the minimal occlusive volume (20-35 cmH#O) and monitored continuously throughout the procedure. Cuff pressure measurements are obtained at defined intraoperative time points, including after pneumoperitoneum, following positioning, and periodically during surgery. Postoperative evaluation includes structured interviews at 2 and 24 hours after extubation to document throat-related symptoms such as sore throat, hoarseness, dysphagia, and cough. The study seeks to provide practical evidence on whether robotic surgical positioning and pneumoperitoneum contribute to elevated cuff pressure and subsequent airway discomfort. These findings may highlight the need for continuous cuff pressure monitoring and adjustment during robot-assisted procedures to improve patient safety and postoperative comfort.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40 to 80 years
- •Classified as American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective robot-assisted laparoscopic radical prostatectomy (RALP) or open radical prostatectomy under general anesthesia
- •Able to understand the study procedure and provide written informed consent
排除标准
- •• Emergency surgery
- •Upper or lower respiratory tract infection within 10 days before surgery
- •ASA physical status > III
- •Obstructed or kinked intraoperative endotracheal tube
- •Risk of aspiration (e.g., gastroesophageal reflux, full stomach)
- •Preoperative sore throat or existing pharyngolaryngeal symptoms
- •Body mass index (BMI) > 35 kg/m²
结局指标
主要结局
Incidence of Postoperative Pharyngolaryngeal Complications
时间窗: Within 24 hours postoperatively
Presence of cough assessed at 2 and 24 hours after extubation.
Change in Endotracheal Tube Cuff Pressure During Surgery
时间窗: Intraoperative period (from induction to end of surgery)]
Endotracheal tube cuff pressure will be continuously monitored from intubation (T1) through various intraoperative stages, including pneumoperitoneum, Trendelenburg positioning, and desufflation
次要结局
未报告次要终点