Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
研究概览
简要总结
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.
TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.
详细描述
During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).
60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.
After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.
The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
- •18~70 years old
- •American society of anesthesiologists physical status 1-2
- •Body mass index < 30 kg/m2
排除标准
- •Contraindication for nitrous oxide
- •Difficult intubation
- •Cormack-Lehane grade > 3
- •Airway-related or pulmonary diseases
- •Short or long operation time (< 1 hour or > 3 hours)
结局指标
主要结局
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
时间窗: One hour after the exposure to nitrous oxide under general anesthesia
次要结局
- Postoperative sore throat: incidence(About 1, 6, 24 hours after termination of anesthesia)
- Postoperative dysphagia: incidence(About 1, 6, 24 hours after termination of anesthesia)
- Postoperative hoarseness: incidence(About 1, 6, 24 hours after termination of anesthesia)
- Intracuff pressure of the endotracheal tubes(0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide)
研究者
Junyong In, MD
Associate Professor
DongGuk University