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临床试验/NCT07726472
NCT07726472已完成不适用

Accuracy of Placement and Performance Test in Detecting Supraglottic Airway Placement Compared to Fiberoptic View

University of Malaya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placement

研究概览

简要总结

The goal of this cross sectional observational study is to compare the accuracy of placement and performance tests to gold standard method of fiberscope assisted insertion of Supraglottic Airway(SGA) Device for optimal SGA placement, in ASA 1-3 adult patients undergoing general anesthesia in University Malaya Medical Center(UMMC). This study aim to answer:

-Can placement and performance tests, ie; Oropharyngeal leak(OPL) test, accurately assess for optimal SGA placement?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology(ASA) class 1-3.

排除标准

  • Patients with limited mouth opening.
  • Patients with pharyngeal or laryngeal abnormalities that affect SGA placement.
  • Patients with high risk of aspiration (gastroparesis, inadequate fasting time, hiatal hernia)
  • Patients with reduced lung or chest compliance or increase airway resistance (ARDS, asthma)
  • Patients with lower safe apneoic time (pregnancy, morbid obesity, sepsis, active lung disease)

结局指标

主要结局

Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placement

时间窗: From enrollment until end of surgery in recovery.

OPL test is part of the listed performance test done to evaluate ideal SGA placement and function for ventilation of GA patients. It is measured in cmH20. Positive test is indicated when the value is \>25cmH20.

次要结局

  • Accuracy of gastric test in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of suprasternal notch test in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of Maximal minute ventilation test in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of subjective assessment(chest rise) in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of subjective assessment(expired tidal volume) in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of subjective assessment(end tidal CO2 waveform) in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)
  • Accuracy of subjective assessment(audible leak) in evaluating optimal SGA placement.(from enrollment until end of surgery, in recovery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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