NCT04520555已完成不适用
Comparison of Recovery Profiles Between Flexible Laryngeal Mask Airway and Tracheal Intubation in Nasal Bone Fracture
Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- cough during extubation
研究概览
简要总结
In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture
排除标准
- •Patients with high risk of aspiration, patients who anticipated difficult airway
结局指标
主要结局
cough during extubation
时间窗: From end of surgery to extubation
Grade of cough during periextubation periods (0=no cough, 1=single cough, 2=more than one episode of non-sustained cough, 3=sustained and repetitive cough with head lift)
次要结局
- Changes of blood pressure(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
- Changes of heart rate(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
- Number of Participants with airway complications after extubation(From extubation to 5 minutes after extubation)
- Adequate tidal volume during mechanical ventilation(From insertion of airway device to extubation)
- Adequate ventilation during mechanical ventilation(From insertion of airway device to extubation)
- Airway pressure during mechanical ventilation(From insertion of airway device to extubation)
- Number of Participants with blood contamination at vocal cord and distal trachea(Between the end of surgery and extubation)
- Number of Participants with postoperative airway complications(30 minutes after surgery and postoperative 1 day)
- Changes of saturation(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
- Device blood contamination(At airway device removal)
- Time to eye opening and time to extubation(From anesthetic discontinuation to eye opening and extubation)
研究者
Jong Yeop Kim
Principal investigator
Ajou University School of Medicine
研究点 (2)
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