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临床试验/NCT03524586
NCT03524586已完成不适用

Comparison of the Endotracheal Tube Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head During Tympanoplasty; Prospective Study.

Kyungpook National University Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
The endotracheal tube cuff pressure

研究概览

简要总结

This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head.

The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.

详细描述

The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.

Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.

In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia

排除标准

  • history of difficult intubation, limited neck movement, respiratory diseases, and body mass index >35kg/m2

研究组 & 干预措施

Ipsilateral rotation of head

Experimental

Head was laterally rotated to the same side against fixed tube

干预措施: Ipsilateral rotation of head (Procedure)

Contralateral rotation of head

Active Comparator

Head was laterally rotated to the opposite side against fixed tube

干预措施: Contralateral rotation of head (Procedure)

结局指标

主要结局

The endotracheal tube cuff pressure

时间窗: During procedure

The endotracheal tube cuff pressure was checked using a manometer

次要结局

  • The distance from the endotracheal tube tip to the carina(During procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saeyoung Kim, MD, PhD

Associate professor

Kyungpook National University Hospital

研究点 (2)

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