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临床试验/NCT01346384
NCT01346384已完成不适用

Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
intracuff pressure

研究概览

简要总结

The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

详细描述

Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.

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
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist physical status I or II
  • Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

排除标准

  • Height was < 155 or >180 cm (for the use of laryngeal tube size 4)
  • Body mass index ≥35 kg/m2
  • Preexisting laryngotracheal disease
  • Risk of pulmonary aspiration of gastric contents.

结局指标

主要结局

intracuff pressure

时间窗: 1-4 hours

measured intracuff pressure of LT with N2O during intraoperative period

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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