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临床试验/NCT04390893
NCT04390893Unknown不适用

Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial

Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
104
试验地点
1
主要终点
Ultrasound scoring system

研究概览

简要总结

Compare the accuracy of two methods of ultrasound and air leakage test in positioning laryngeal mask. Validate the relationship between ultrasound scores, air leak levels, and bronchoscopic classification in positioning laryngeal mask

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients selected for this study must meet all of the following criterion:
  • Age is between 17 to 65 years old;
  • ASA (Amecican Society of Anesthesiology ) scores I-II;
  • Actual weight is between 30 to 100 kilogram;
  • Patients undergo selective supine operations under general anesthesia (laryngeal mask);
  • Patients agree to participate in our study and sign Informed Consent Form

排除标准

  • Patients cannot participate in this study if they have any of the following conditions:
  • Airway stenosis, history of airway masses etc, whicn may cause obstruction to ventilation;
  • Swelling of the neck caused by huge mass in the neck and history of neck surgery etc, which doesn't contribute to ultrasound observation;
  • Stomach fullness, intestinal obstruction, gastroesophageal reflux disease etc, which may cause reflux aspiration.

结局指标

主要结局

Ultrasound scoring system

时间窗: during procedure (after laryngeal mask's placement)

Anesthesiologist who are familiar with ultrasound would scan three planes of neck

Air leakage test grading system

时间窗: during procedure (after laryngeal mask's placement)

Anesthesiologist would auscultate the degree of leakage

Fiberoptic scoring system

时间窗: procedure (after ultrasound examination or leakage test)

Anesthesiologist would confirm the position of LMA by fiberscope

次要结局

  • Complications related to LMA (laryngeal mask airway )(24 hours after surgery)

研究者

发起方
Shenzhen Second People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ZhiHeng Liu

Head of Anesthesiology Department

Shenzhen Second People's Hospital

研究点 (1)

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