Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intracuff Pressure
研究概览
简要总结
The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The randomization table of a treatment sequence will be managed by the third person who will not involve in this study.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I, II
- •Body mass index < 30 kg/m2
- •Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position
排除标准
- •History of airway-related or pulmonary diseases/abnormalities
- •When difficult intubation is anticipated
- •History of general anesthesia within the past 3 months
- •Pregnancy
- •History of smoking
研究组 & 干预措施
Cuff sealing by MOVT
MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured.
干预措施: MOVT (Procedure)
Cuff sealing by VE/VI ratio
VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured.
干预措施: VE/VI ratio of Spirometer (Procedure)
结局指标
主要结局
Intracuff Pressure
时间窗: From the start of cuff inflation to the airway sealing, an average of 2 minutes
The intracuff pressure of endotracheal tube when cuff sealing is achieved.
次要结局
- Intracuff air volume(From the start of cuff inflation to the airway sealing, an average of 2 minutes)
研究者
Junyong In, MD, PhD
Professor
DongGuk University