Ultrasound Versus Palpation to Find Optimal Endotracheal Tube Cuff Position in Pediatric Patients Receiving Head and Neck Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- percentage of the patients whose cuff is optimally located.
研究概览
简要总结
A. The hypothesis of this study is "Airway ultrasound will be superior to the conventional methods of auscultation and palpation in confirming proper positioning of the endotracheal tube in children undergoing endotracheal intubation with an endotracheal tube with cuff".
B. The purpose of this study is to determine the utility of airway ultrasound in confirming proper positioning of the endotracheal tube.
C. In addition, we would like to suggest what criteria should be used when using airway ultrasound to determine the fixed position of an endotracheal tube.
详细描述
- Obtain consent from the guardian of the target patient before surgery and perform randomization.
- After entering the operating room, attach equipment for electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation, anesthesia depth monitoring, and neuromuscular blockade monitoring.
- Prepare the endotracheal tube according to the patient's age. 6 months to 18 months: internal diameter 3.5 18 months to 2 years: internal diameter 3.5 or 4.0 2-4 years: internal diameter 4.0 4 to 5 years: internal diameter 4.5 5 years and older: Age/4 + 3.5
- When sufficient neuromuscular blockade is achieved after infusion of neuromuscular blocking agents, after inserting the endotracheal tube, check the position of the endotracheal tube according to the assigned group, fix the endotracheal tube in consideration of changes in posture during surgery, and record its depth.
Ultrasound group A. During tracheal intubation using a video laryngoscope, the endotracheal tube is stopped when the endotracheal tube cuff passes through the vocal cord.
B. Use ultrasound to check the position of the endotracheal tube cuff, check its movement according to the surgical position, and position the cuff according to the size of the endotracheal tube as follows.
- internal diameter 3.5, internal diameter 4.0: The cuff is positioned 0.5 cm below the lower margin of the cricoid cartilage.
- internal diameter 4.5, internal diameter 5.0: The cuff is positioned 1 cm below the lower margin of the cricoid cartilage.
C. In the final position, check for bilateral lung movement (lung sliding sign) using lung ultrasound.
D. Record the depth of fixation of the endotracheal tube.
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
- None
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 6 months to 7 years who are scheduled to have an endotracheal tube inserted for facial or intraoral surgery.
排除标准
- •When difficult intubation is anticipated
- •If the patient has deformities such as facial asymmetry due to congenital causes such as genetic diseases or acquired causes such as accidents.
- •If the patient or guardian does not agree to participate in the study.
- •Other cases deemed unsuitable by the researcher
结局指标
主要结局
percentage of the patients whose cuff is optimally located.
时间窗: at the end of the surgery
Percentage of patients with endotracheal tube cuff located below the cricoid lower margin and at a depth that allows movement of both lungs, as confirmed by postoperative ultrasound.
次要结局
- incidence of postoperative complication(at postanesthetic care unit)
- Differences in final endotracheal tube fixation depth in the two groups(at the end of induction of anesthesia)
- Incidence of respiratory events(throughout the surgery)
- proportion of final cuff position(at the end of the surgery)
研究者
Eun-hee Kim
Clinical associate professor
Seoul National University Hospital