Effects of Endotracheal Tube Cuff Pressure Management on Upper Airway Edema During Cardiopulmonary Bypass in Coronary Artery Bypass Grafting: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
研究概览
简要总结
This study investigates how endotracheal tube (ETT) cuff pressure management during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) affects upper airway edema. Patients will be randomized into two groups: cuff pressure kept at 0 mmHg or maintained at 20-30 mmHg during CPB. Ultrasonography will be used to measure lateral pharyngeal wall thickness, tongue parameters, and other airway dimensions at predefined perioperative time points. The primary outcome is the change in lateral pharyngeal wall thickness as an indicator of airway edema. A total of 76 patients aged 18-80 years undergoing elective CABG with CPB will be enrolled. The results aim to clarify safe cuff pressure management strategies to reduce airway edema.
详细描述
Purpose This study aims to evaluate the effect of endotracheal tube (ETT) cuff pressure management during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) surgery on the development of upper airway edema. Ultrasonography will be used to assess changes in lateral pharyngeal wall (LPW) thickness, tongue thickness, correlation between intravenous fluid volume at multiple perioperative time points.
Study Design
This is a prospective, randomized, double-blind, controlled clinical trial. Patients undergoing elective CABG with CPB will be randomly assigned into two groups:
Group 1: ETT cuff pressure maintained at 0 mmHg during CPB Group 2: ETT cuff pressure maintained at 20-30 mmHg during CPB Cuff pressures will be monitored with a manometer every 5 minutes and adjusted as needed. At the end of CPB, all patients will have standard cuff pressure (20-30 mmHg).
Outcomes Primary outcome: Changes in LPW thickness as a marker of upper airway edema assessed by ultrasonography at five time points (T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective coronary artery bypass grafting (CABG) surgery
- •Aged 18-80 years
- •ASA physical status class III-IV
- •Providing written informed consent
排除标准
- •History of difficult intubation
- •Anatomical abnormalities of the upper airway
- •Body mass index (BMI) > 35 kg/m²
- •Acute respiratory tract infection
- •Emergency surgeries
研究组 & 干预措施
ETT cuff pressure 20-30 mmHg
ETT cuff pressure will be set to 20-30 mmHg
干预措施: ETT cuff pressure 20-30 mmHg (Device)
ETT cuff pressure 0 mmHg
ETT cuff pressure will be set to 0 mmHg
干预措施: ETT cuff pressure 0 mmHg (Device)
结局指标
主要结局
Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
时间窗: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
To compare the effect of two different endotracheal tube (ETT) cuff pressures (0 mmHg vs. 20-30 mmHg) during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on upper airway edema. The degree of airway edema will be assessed by measuring changes in lateral pharyngeal wall thickness (in millimeters, mm) using ultrasound at predefined perioperative time points.
Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
时间窗: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
To compare the effect of two different endotracheal tube (ETT) cuff pressures (0 mmHg vs. 20-30 mmHg) during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on upper airway edema. The degree of airway edema will be assessed by measuring changes in lateral pharyngeal wall thickness (in millimeters, mm) using ultrasound at predefined perioperative time points.
次要结局
- ultrasonographic airway parameter -tongue width(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
- ultrasonographic airway parameter -tongue volume(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
- Correlation Between Intravenous Fluid Volume and Airway Edema(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
- Correlation Between Intravenous Fluid Volume and Airway Edema(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
- ultrasonographic airway parameter -tongue width(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
- ultrasonographic airway parameter -tongue volume(T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour)
研究者
Engin Çetin
principal investigator
Kocaeli City Hospital